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. 2018 Jun 21;2018(6):CD007105. doi: 10.1002/14651858.CD007105.pub4

Shahin 2010.

Methods Double‐blinded (participant/outcome assessor), placebo/sham‐controlled, randomized clinical trial
Sequence generation by computer‐generated random numbers
Follow‐up: 8 months
Participants Participants: parturients in a university setting in Assiut, Egypt
Operation: caesarean section for delivery
groups, size: 185/185
Age: 25 years (SD ± 1.5 )
Men/women (group 1, 2): 0/185, 0/185
Comorbidities (group 1/2/3): none reported
Remarks:
Interventions Group 1 (intraperitoneal lidocaine instillation): spinal (details not reported), postincision, preperitoneal closure single‐shot instillation of peritoneal lidocaine (2%, 10 mL) into the pelvis, post‐op paracetamol 1 g intravenously every 6 h for 36 h, rectal suppository of 10 mg followed by oral 400 mg ibuprofen for 72 h, plus intravenous morphine 2 mg for breakthrough pain
Group 2 (intraperitoneal placebo/saline instillation): spinal (details not reported), postincision, preperitoneal closure single‐shot instillation of peritoneal saline (0.9%, 10 mL) into the pelvis, post‐op paracetamol 1 g intravenously every 6 h for 36 h, rectal suppository of 10 mg followed by oral 400 mg ibuprofen for 72 h, plus intravenous morphine 2 mg for breakthrough pain
Adjuvants: none
Immediate post‐op pain control: significantly improved
Outcomes Dichotomous: overall pain/no pain at 8 months, differentiated also in wound, global abdominal and epigastric pain
Continuous: at 8 months: NRS
Notes Funding sources: "No ... funding acknowledgement was declared by either of the authors."
Conflicts of interest: the study authors have no conflict of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐based random allocation
Allocation concealment (selection bias) Low risk Placed in sealed, opaque, consecutively numbered envelopes... just after providing consent the women were given the next number on the random list..., (allocation) was concealed from the residents and caregivers
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "the surgeon involved complied with the instruction but was not further involved" data "collection sheets with corresponding codes,.. a number of syringes equal in size;" "preparation and administration of the medication was carried out by a nurse not involved in the management of the patient", "access to randomization code was only available to the secretary of the statistics department", "randomization code was not broken until the completion of the study".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "access to randomization code was only available to the secretary of the statistics department", "randomization code was not broken until the completion of the study".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Analysis was per protocol, not ITT, but the low number of participants lost to follow‐up with almost equal attrition in both groups and the similar demographics in both groups make bias unlikely.
Selective reporting (reporting bias) Low risk No protocol available but all outcomes specified in the article were reported on.
Null bias Low risk Quote: "control group patients received significantly more morphine injections in the first 24 hours than lidocaine patients". Significantly more participants in the control group reported pain in all sites in the first 24 h than in the lidocaine group.