lippincott williams & wilkins€¦  · web viewstudy (author-year) study design. subjects (cs,...

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Supplement: Supplemental information 1: list of excluded studies with reasons for exclusion Autor study year reason for exclusion Abalos 2013 study protocol Abbaspoor 2014 no chronic pain data (>3 months) reported Abdallah 2012 review Abdool 2009 review Ajeet 2013 no chronic pain data (>3 months) reported Almeida 2002 selected population Alpay 2008 review Amata 1999 no chronic pain data (>3 months) reported Andreae 2012 review Ansara 2005 no chronic pain data (>3 months) reported Babel 2015 no chronic pain data (>3 months) reported Babski- Reeves 2006 no chronic pain data (>3 months) reported Bai 2013 no chronic pain data (>3 months) reported Baksu 2007 only sexual-intercourse- associated pain Balich 1986 language: rus Bamigboye 2014 review Bergstrom 2010 no chronic pain data (>3 months) reported Bhatia 2012 commentary Bjelland 2013 selected population (PGS 30.SSW) Buhling 2006 only sexual-intercourse- associated pain Carvalho 2013 no chronic pain data (>3 months) reported Chandon 2014 no chronic pain data (>3 months) reported Chersich 2009 mixed population Chooi 2013 no chronic pain data (>3 months) reported Clark 2011 review

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Page 1: Lippincott Williams & Wilkins€¦  · Web viewStudy (author-year) Study design. Subjects (CS, vaginal, planned, emergency) Intervention/Control. Pain follow-up (time points ≥

Supplement:

Supplemental information 1: list of excluded studies with reasons for exclusion

Autor study year reason for exclusionAbalos 2013 study protocolAbbaspoor 2014 no chronic pain data (>3 months) reportedAbdallah 2012 reviewAbdool 2009 reviewAjeet 2013 no chronic pain data (>3 months) reportedAlmeida 2002 selected populationAlpay 2008 reviewAmata 1999 no chronic pain data (>3 months) reportedAndreae 2012 reviewAnsara 2005 no chronic pain data (>3 months) reportedBabel 2015 no chronic pain data (>3 months) reportedBabski-Reeves 2006 no chronic pain data (>3 months) reportedBai 2013 no chronic pain data (>3 months) reportedBaksu 2007 only sexual-intercourse-associated painBalich 1986 language: rusBamigboye 2014 reviewBergstrom 2010 no chronic pain data (>3 months) reportedBhatia 2012 commentaryBjelland 2013 selected population (PGS 30.SSW)Buhling 2006 only sexual-intercourse-associated painCarvalho 2013 no chronic pain data (>3 months) reportedChandon 2014 no chronic pain data (>3 months) reportedChersich 2009 mixed populationChooi 2013 no chronic pain data (>3 months) reportedClark 2011 reviewClay 2011 reviewCohen 2013 selected population (Re-Sectio)Connolly 2005 only sexual-intercourse-associated painCorosu 1999 no chronic pain data (>3 months) reportedCostello 2009 no chronic pain data (>3 months) reportedDabiri 2014 only sexual-intercourse-associated painDaye 1993 selected population (seen by General Surgery

Service)de la Cruz 2013 selected population (peripartum

Hysterectomy)de Souza 2015 only sexual-intercourse-associated paindo Carmo Leal 2012 study protocolDodd 2004 no chronic pain data (>3 months) reportedDodd 2008 reviewDrew 2008 selected population (back pain, keine zeitliche

Einordnung möglich)Ducic 2006 selected population (neuroma resection)Edi-Osagie 1998 no chronic pain data (>3 months) reported

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Eid 2015 only sexual-intercourse-associated painEl-Shawarby 2011 selected populationEnabudoso 2011 no chronic pain data (>3 months) reportedFawcett 1994 no chronic pain data (>3 months) reportedFigueroa 2013 no chronic pain data (>3 months) reportedFitzgerald 2013 editorialFrishman 1997 no chronic pain data (>3 months) reportedGates 2013 reviewGhahiry 2012 no chronic pain data (>3 months) reportedGiacalone 2002 no chronic pain data (>3 months) reportedGizzo 2015 reviewGjerdingen 1993 no chronic pain data (>3 months) reportedGoetsch 1999 no chronic pain data (>3 months) reportedGueye 2013 selected populationGutierrez 2008 no chronic pain data (>3 months) reportedHaines 2012 no chronic pain data (>3 months) reportedHemanth 2014 no chronic pain data (>3 months) reportedHofmeyer 2003 reviewHosseini 2012 only sexual-intercourse-associated painHowell 2010 no chronic pain data (>3 months) reportedHuang 2012 no chronic pain data (>3 months) reported

(QoL)Huchon 2005 no chronic pain data (>3 months) reportedHuppelschoten 2013 no chronic pain data (>3 months) reportedIbrahim 2014 no chronic pain data (>3 months) reportedIslam 2011 no chronic pain data (>3 months) reportedJuntunen 2004 selected population (4th-10th CS)Juul 1988 no chronic pain data (>3 months) reportedKabakian-Khasholian

2013 no chronic pain data (>3 months) reported

Kabakian-Khasholian

2015 only sexual-intercourse-associated pain

Kato 2013 case reportKealy 2010 no chronic pain data (>3 months) reportedKnoche 1982 no chronic pain data (>3 months) reportedLandau 2010 reviewLandau 2013 reviewLatif 2013 no chronic pain data (>3 months) reportedLatthe 2006 reviewLavand`homme 2006 reviewLavand`homme 2010 editorialLavand`homme 2013 reviewLavender 2012 reviewLiebling 2004 only defecation-associated painLoos 2008 mixed populationLoos 2008 mixed populationMacArthur 1995 no chronic pain data (>3 months) reported

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MacArthur 1993 no chronic pain data (>3 months) reportedMackeen 2012 reviewMathai 2013 reviewMcDonald 2015 only sexual-intercourse-associated painMcKeen 2014 no chronic pain data reported (SF-36)Mehdizadeh 2005 no chronic pain data (>3 months) reportedMens 1996 no chronic pain data (>3 months) reportedMistrangelo 2014 case reportMogren 2007 selected population (LBPP during pregnancy)Molkenboer 2008 no chronic pain data (>3 months) reportedMukkannavar 2014 no chronic pain data (>3 months) reportedNaderi 2007 commentaryNajafi 2014 no chronic pain data (>3 months) reportedNaskar 2012 no chronic pain data (>3 months) reportedNuthalapaty 2013 no chronic pain data (>3 months) reportedOlofinbiyi 2015 no chronic pain data (>3 months) reportedOsis 2001 no chronic pain data (>3 months) reportedPaech 2006 no chronic pain data (>3 months) reportedRaimondo 2015 selected population, isthmoceleRaven 2015 no chronic pain data (>3 months) reportedRedshaw 2010 no chronic pain data (>3 months) reportedRousseau 2009 no chronic pain data (>3 months) reportedRowlands 2012 no chronic pain data (>3 months) reportedRussell 1993 mixed populationSafarinejad 2009 only sexual-intercourse-associated painSamadi 2010 no chronic pain data (>3 months) reportedSchytt 2011 no chronic pain data (>3 months) reportedSchytt 2005 mixed populationSeid 2013 no chronic pain data (>3 months) reportedSharif 2009 reviewSilver 2010 reviewSimpson 2009 recommendationSingal 2014 selected populationStark 2008 selected population (Re-Sectio)Steinemann 2013 no chronic pain data (>3 months) reportedStramrood 2011 no chronic pain data (>3 months) reportedTakeshima 2006 language: chiTappauf 2013 no chronic pain data (>3 months) reportedTihtonen 2014 language: finTong 1999 language: jpnTower 2013 reviewTuuli 2011 reviewVermelis 2010 reviewWaldenstrom 1999 no chronic pain data (>3 months) reportedWaldenstrom 2006 no chronic pain data (>3 months) reportedWang 2009 selected populationWilliams 2007 no chronic pain data reported for CS

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Xu 2013 language: chiYeniel 2014 only sexual-intercourse-associated painZirak 2012 no chronic pain data (>3 months) reported

Supplemental information 2: Characteristics of included studies (see separate file)

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Supplemental information 3: Subgroup analysis_RCT vs. observational studies

Incidence of chronic pain at 3 to < 6 month after CS

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Incidence of chronic pain at 6 to < 12 month after CS

Incidence of chronic pain at ≥ 12 month after CS

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Supplemental information 4: Double arcsine transformation

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Supplemental information 5: Best-case/worst-case meta-analysis

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Supplemental information 6: Chronic pain severity assessment

Page 10: Lippincott Williams & Wilkins€¦  · Web viewStudy (author-year) Study design. Subjects (CS, vaginal, planned, emergency) Intervention/Control. Pain follow-up (time points ≥

Study (author-year)

Severity outcomes (time; scale)

Severity assessment (pain patients/ all patients)

Pain rating Summary measure (mean, median, other)

Pain score

Aabakke-2013 3 & 6 mo; 0 to 10 NRS

All patients Side with more pain (staples vs. Subcuticular suture)

Mean difference (CI)

3 mo: -0.1 (-0.25-0.01), 6mo: -0.2 (0.0-0.4)

Aabakke-2014 3 mo; 0 to 10 NRS

All patients At rest & mobilization

Median (IQR) 0.0 (0.0-0.0) vs. 0.0 (0.0-0.0)

Belci-2014 > 5 years; 0 to 10 VAS

Unclear at time of outpatient visit

Mean 1.2 vs 0.3 VAS

Bilgen-2012 6 mo, 1 year; no, mild, moderate, severe

All patients (pain patients: 8 at 6 mo, 3 at 1year)

Unclear Number of women with mild pain

6 mo: 8/140 with mild pain (8 pain patients), 1 yr: 3/140 with mild pain (3 pain patients)

Blomquist-2014 > 6 years; moderate to severe pain as determined by the Oxfordshire Women´s Health Study Questionnaire

All patients (120 pain patients)

Unclear Number of women with moderate/severe pain

30/555 (120 pain patients)

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Bollag-2012 3, 6, & 12 month; 0 to 10 VAS

All patients Current pain intensity

Mean (SD) 3 mo: 0.1 (0.56) vs. 0.24 (1.2) vs. 0 (0), 6 mo: 0.04 (0.19) vs. 0 (0) vs. 0 (0), 12 mo: 0 (0) vs. 0 (0) vs. 0 (0)

Eisenach-2013 6 mo; 0 to 10 VRS

Pain patients

Average in last week, worst in last week, now

Mean (SD) Average in last week: 2.0 (1.3), worst in last week: 1.8 (1.0), now: 1.0 (1.3)

Fatusic-2011 12 weeks; SF-36 (0 to 100; higher scores indicating a better condition)

All patients SF-36; bodily pain

Mean (SD) ML: 74.7 (13.6), PF: 61.2 (18.7)

Hannah-2002 3 mo; Amount of pain (none, almost none, mild or small, quite a lot, severe)

All patients (302 pain patients)

Pain within the previous 24h

Number of women with different amount of pain

any pain; none (763/1065), almost none (36/1065), mild or small (217/1065), quite a lot (48/1065), severe (1/1065)

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Hannah-2004 2 years; Amount of pain (none, almost none, mild or small, quite a lot, severe)

All patients (137 pain patients)

Unclear Number of women with different amount of pain

any pain; none (474/611), almost none (4/611), mild or small (72/611), quite a lot (45/611), severe (13/611)

Kainu-2010 1 year; 0 to 10 VAS; VRS (mild, moderate, intense, unbearable)

Pain patients

Average pain, at rest, when coughing, during deep breathing

Number of women with different amount of pain

VRS (mild (23/42), moderate (13/42), intense (4/42), unbearable (0/42)); VAS at rest (0-2 (33/42), 3-5 (4/42), 6- (0/42))

Lavand´homme-2008

3 & 6 mo; 1 to 5 VRS (1 = slight, 2 = mild, 3 = moderate, 4 = high, 5 = very high pain)

Pain patients

Pain today Median (IQR) 3 mo: 2.3 (1.6-2.9) vs. 2 (1.3-2.8) vs. 1.5; 6 mo: 3 (2.5-3.5) vs. 2 (1.5-2.5) vs. 1

Liu-2013 12 month; VRS (nil, mild, moderate, severe)

All patients ( 18 pain patients)

Pain patients with different frequency of pain ( constant to interval of weeks)

Number of women with different amount of pain

VRS (nil (408/426), mild (17/426), moderate (1/426), severe (0/426))

Moore-2011 3 month; 0 to 10 NRS

Pain patients

Unclear Median (IQR) 3 (1-4) vs. 2.5 (1-5)

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Nardi-2013 8-13 months; VRS: absente, faible, modéré et intense

Pain patients

At rest and activity

Number of women with different amount of pain

VRS: fréquence: mensuelles 11/25; Hebdomadaires 5/25; Quotidiennes 5/25; constantes 4/25; intensité au repos: absente 10/25, faible 9/25, modéré 4/25 et intense 2/25 ou a l'effort:absente 4/25, faible 9/25, modéré 10/25 et intense 2/25

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Niklasson-2015 3, 6 & 12 month; 1 to 10 NRS (1-3 = mild, 4-6 = moderate, 7-8 = severe, 9-10 = very severe)

Pain patients

at present and during the last week, average pain

Number of women with different amount of pain

3 mo: mild (31/93), moderate (54/93), severe (7/93), very severe (1/93); 6 mo: mild (25/63), moderate (25/63), severe (13/63), very severe (0/63); 12 mo: mild (15/46), moderate (18/46), severe (11/46), very severe (2/46)

Nikolajson-2004

6-18 month; VRS (not present, mild, moderate, severe)

Pain patients

at rest & during physical activity

Number of women with different amount of pain

at rest: not present (13/27), mild (7/27), moderate (7/27), severe (0/27); at activity: not present (2/27), mild (12/27), moderate (11/27), severe (2/27);

Schindl-2003 4 month; 0 to 10 VAS

All patients momentary birth-related

Median 4 mo: 0.5 (emergeny CS), 0.0 (CS on demand)

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Shahin-2009 8 month; 0 to 10 NRS

Pain patients

Unclear Mean (SD) Closure group: 3.8 (2.2), Non-closure group: 3.2 (1.8)

Shahin-2010 9 month; 0 to 10 NRS

Pain patients

At rest Mean (SD) Saline group: 3.6 (0.8), lidocaine group: 2.3 (0.4)

Sia-2010 6 month; moderate pain at rest/ activity

Pain patients

rest & activity

Number of women with moderate pain at rest/activity

6 mo: 3/18 experienced daily pain, 2 had at least moderate pain, the other one experienced pain during activities

Singh-2013_a 12 weeks; 0 to 10 NRS

All patients Unclear Mean (SD) 12 weeks: high 0.4 (0.9), low 0.1 (0.3), placebo 0 (0)

Singh-2013_b 13 weeks; 0 to 10 NRS

All patients Unclear Overall Mean 12 weeks: 0.3 (1.5 mg), 0.5 (3 mg)

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Sng-2009 12-20 month; VRS (not present, mild, moderate, severe)

Pain patients

At rest & activity

Number of women with different amount of pain

at rest: not present (24/51), mild (25/51), moderate (1/51), severe (1/51); at activity: not present (3/51), mild (39/51), moderate (8/51), severe (1/51);

Study (author-year)

Study design Subjects (CS, vaginal,

Intervention/Control Pain follow-up

Initial n (CS), n at follow-up/analyzed

localisation of pain

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planned, emergency)

(time points ≥ 3 month)

Aabakke-2013 RCT scheduled CS

Staples vs. Subcuticular suture (side distribution analysis)

3 & 6 month

n = 59, 58 at 3 mo, 59 at 6 mo

scar

Aabakke-2014 RCT scheduled primary CS

Sharp vs. Blunt opening of the fascia (side distribution analysis)

3 month

n = 34, 28 at 3 mo scar

Belci-2014 retrospective cohort study

CS Pfannenstiel (50) vs. Misgav Ladach (50)

≥ 5 years (mean 10.3 vs. 7.8)

n = 100, 100 at > 5 year incisional scar & lower abdomen

Bilgen-2012 RCT CS 1: ketamine 0.25 mg/kg, 2: ketamine 0.5 mg/kg, 3: ketamine 1 mg/kg, 4: saline

6 month & 1 year

n = 140, 140 at 6 mo and 1 year

postoperative pain

Blomquist-2014 longitudinal cohort study

CS & vaginal

no intervention 6 to 11 years

initial n (CS) unclear, 577 at follow-up/555 analyzed

pelvis

Bollag-2012 RCT non-labouring women, scheduled for CS

1: saline TAP, 2: bupivacaine TAP, 3: bupivacaine + clonidine TAP

3, 6, & 12 month

n = 90, return rate: 29/25/23 at 3 mo, 28/24/23 at 6 mo, 28/20/22 at 12 mo

abdominal wound

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de Brito Cancado-2012

RCT CS (elective and emergency)

5 (G1-G5) groups with different doses of hyperbaric bupivacaine and opioids in spinal anaesthesia

3 month

n = 443, 402 at 3 mo follow-up

abdominal, pelvic, scar pain

Declercq-2008 National survey

CS & vaginal

no intervention 6 month

n = 503, 357 at 6 mo follow-up

incision

Driul-2011 cohort study CS & vaginal

no intervention > 6 month

n = 149 pelvis

Eisenach-2013 cohort study CS & vaginal

no intervention 6 & 12 month

n = 391, 6 at 6 mo, 0 at 12 mo

incision, pelvis, back

Eldaba-2013 RCT elective CS 1: bupivacaine, 2: bupivacaine + MgSO4, 3: saline

3 month

n = 120, 120 at 3 mo follow-up

residual pain

Fatusic-2011 RCT repeated CS

1: ML, 2: PF 12 weeks

n = 145, 145 at 12 weeks follow-up

bodily pain

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Hannah-2002 Follow-up study to the Term Breech Trial (RCT)

CS & vaginal

1: planned CS, 2: planned vaginal

3 month

n = 972 (planned CS), 798 (planned CS) at follow-up, 723 (planned CS delivered with CS) + 342 (CS from the planned vaginal group)

outside of abdomen, back, genital area, any pain

Hannah-2004 Follow-up study to the Term Breech Trial (RCT)

CS & vaginal

1: planned CS, 2: planned vaginal

> 2 years

n = 580 (planned CS), 457 (planned CS) at follow-up: 408 (planned CS delivered with CS) + 203 (CS from the planned vaginal group)

outside of abdomen, back, genital area, any pain

Hartfield-1973 cohort study CS 1: CS, 2: Symphysiotomy

20 month to 10 years

n = 105, 48 at follow-up

unexplained abdominal pain, back ache

Kainu-2010 cohort study CS & vaginal

no intervention > 5 mo (no longer), 1 year

n = 300, 229 at follow-up

surgical site

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Lavand´homme-2008

RCT elective CS 1: bupivacaine-sufentanil, 2: bupivacaine-sufentanil-clonidine, 3: bupivacaine-clonidine

3 & 6 month

n = 96, 90 at 3 & 6 mo follow-up

scar pain /visceral pain

Lavand`homme-2007

RCT elective CS 1: diclofenac, 2: ropivacaine, 3: saline

6 month

n = 92, 90 at follow-up scar

Li-2014 cross-sectional study

CS & vaginal

no intervention 6-12 month, 1-5 years, 5-10 years, >10 years

n = 766, 157 at 6-12 mo, 204 at 1-5 years, 222 at 5-10 years, 183 at >10 years

pelvis

Liu-2013 cohort study elective & emergency CS

no intervention 12 month

n = 469, 426 at follow-up

abdominal wound

Loane-2012 RCT CS 1: morphine + sham TAP, 2: TAP with ropivacaine

3 month

n = 69, 59 at follow-up wound

MacArthur-1990

cohort study CS & vaginal

no intervention 1-9 years

n = 1915 back

Moore-2011 RCT CS 1: pre-operative gabapentin, 2: placebo

3 month

n = 46, 36 at follow-up incisional

Moro-2015 prospective observational study

CS no intervention > 12 month

n = 308 low-abdominal

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Nardi-2013 retrospective cohort study

CS no intervention 8-13 months

n = 220; 167 (response rate)

douleurs cicatricielles = incisional pain = scar

Niklasson-2015 prospective long-term follow-up study

elective CS no intervention 3, 6 & 12 month

n = 260, 231 at 3 mo, 228 at 6 mo, 215 at 12 mo

abdomen, back, any

Nikolajson-2004 cohort study CS no intervention >3 to 6-18 month (mean 10.2 month)

n = 220 scar

Page 22: Lippincott Williams & Wilkins€¦  · Web viewStudy (author-year) Study design. Subjects (CS, vaginal, planned, emergency) Intervention/Control. Pain follow-up (time points ≥

O´Neill-2012 RCT CS 1: ropivacaine wound infusion, 2: epidural morphine

3 month

n = 67, 50 at follow-up scar

Patel-2007 cohort study CS (emergency & elective) & vaginal

no intervention 8 month

n = 1153, 942 at 8 mo back

Rackelboom-2010

RCT elective CS 1: wound infusion above the fascia, 2: wound infusion below the fascia

6 month

n = 56, 50 at 6 mo follow-up

scar

Rezaie Kahkhaie-2014

RCT CS 1: Nylon, 2: absorbing polyglactin

6 month

n = 120, no statement on withdrawals/exclusions

scar

Roset-2003 follow-up of a RCT

elective & emergency CS

1: closure of the peritoneum, 2: non-closure of the peritoneum

7 years n = 280, 144 at follow-up

scar

Schindl-2003 prospective observational study

CS (elective and emergency) & vaginal

1: vaginal delivery, 2: medical CS, 3: CS on demand

4 month

n = 240, no statement on the number of CS and vaginal at follow-up

birth-related pain

Shahin-2009 RCT elective CS 1: parietal peritoneal closure, 2: no parietal peritoneal closure

8 month

n = 340, 325 at 8 month follow-up

global abdominal pain

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Shahin-2010 RCT CS 1: intraperitoneal lidocaine, 2: saline

8 month

n = 370, 354 at 8 month follow-up

global abdominal pain

Short-2012 RCT elective CS 1: 300 mg gabapentin, 2: 600 mg gabapentin, 3: placebo

3 month

n = 132, 112 at 3 month follow-up

incisional

Sia-2010 prospective cohort study

elective CS no intervention 3 & 6 month

n = 631, 503 at 3 & 6 month follow-up

abdominal wound scar pain

Singh-2013_a RCT elective CS 1: low-dose ropivacaine, 2: high-dose ropivacaine, 3: placebo

12 weeks

n = 60, 59 at follow-up abdominal

Singh-2013_b randomized non-inferiority trial

elective CS 1: 3 mg epidural morphine, 2: 1.5 mg epidural morphine

13 weeks

n = 90, 87 for analysis abdominal

Sng-2009 prospective cohort study

elective CS no intervention 3 month, 12-20 month (mean 14.5 mo)

n = 857 abdominal wound scar pain

Suppa-2012 RCT elective CS 1: Ketamine, 2: placebo

3 years n = 56, 26 at 3 years follow-up

residual wound pain

Thompson-2002 cohort study CS & vaginal

no intervention 16 weeks and 6 month

N/A back ache

Wang-2010 prospective cohort study

CS & vaginal

no intervention 6-12 month

n = 301, 295 at follow-up

back ache, abdominal pain

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Woolhouse-2012

cohort study CS & vaginal

no intervention 3, 6 & 12 month

n = 431, 426 at 3 mo, 406 at 6 mo, 347 at 12 mo

wound, back, pelvis