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

Besic 2014.

Methods Double‐blinded (patient/outcome assessor), RCT
Sequence generation by a computer‐based, random numbers generator
Follow‐up: 3 months
Participants Participants: 120 women in a hospital setting in Ljubljana, Slovenia
Operation: axillary lymphadenectomy and breast reconstruction
Groups, size: 60/60
Age (lymphadenectomy, reconstruction): 60, 48
All female participants
Comorbidities: none
Interventions Group 1 (levobupivacaine): intraop: before wound closure, a fenestrated wound catheter was placed under the pectoralis major muscle and upon the entire length over the upper side of the wound. The wound catheter was fenestrated along 15 cm in the distal part. A bolus of 15 mL of 0.25% levobupivacaine was injected into the wound through the catheter immediately after wound closure. Surgical drains and the fenestrated catheter were clamped for 5 min to enable bolus absorption. Elastomeric pump was connected containing 100 mL of 0.25% levobupivacaine. Infusion at 2 mL/h was continuous for 50 h.
Group 2 (piritramide): intraop: continuous intravenous infusion with piritramide (30 mg), metoclopramide (20 mg) and metamizole (2.5 g) in 100 mL of 0.9% sodium chloride (3 mL/h‐6 mL/h) until 24 h postoperatively
Adjuvants: none
Immediate post‐op pain control: significantly improved, significantly reduced analgesic consumption
Outcomes Continuous: none
Dichotomus: overall pain/no pain at 3 months
No adverse events reported
Notes Study characteristics and data combined with Strazisar 2014. Axillary lymphadenectomy and breast reconstruction performed on 60 participants per procedure. Results from both procedures were combined to best represent pain outcomes.
Funding sources: financial support was not described.
Conflicts of interest: no conflict of interest statement was provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the research nurse performed randomization using random numbers generated by a computer..."
Allocation concealment (selection bias) Low risk Quote: "randomization and numbers were placed in sealed opaque envelopes to ensure concealment of allocation at enrollment"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "participants were randomly grouped"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "clinicians who recorded data about chronic pain were blinded about randomisation group of patients."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants completed the follow‐up evaluation.
Selective reporting (reporting bias) Low risk No subgroup analysis or selective reporting was noted.
Null bias Low risk Quote: "a smaller portion of patients treated with local anesthetics had chronic pain in comparison to the control group." "Chronic pain three months after operation is less frequent in the test group."