Zhou 2016.
Methods | Double‐blinded, placebo controlled, randomized clinical trial Sequence generation not described Follow‐up for 3 months |
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Participants | Subjects: 106 adults in a university setting in China Operation: craniotomy 2 groups, size: 53/53 Age (± SD), group 1, 2: not described Men/women, group 1, 2: not described Exclusion criteria: not described |
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Interventions |
Group 1 (ropivacaine): after the anesthesia induction, skin along the incision was infiltrated with 0.5% ropivacaine. Morphine was used as rescue analgesic postoperatively. Anaesthetic regimen not further described. Group 2 (control): exactly the same as above except 0.9% saline was substituted for ropivacaine. Adjuvants: none Immediate post‐op pain control: significantly improved |
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Outcomes | Dichotomous: pain vs no pain Continuous: VAS Other reported: morphine consumption, heart rate and mean arterial pressure were recorded before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, and skin closure |
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Notes | We were unable to obtain additional information about randomization and blinding methods from the study author. Funding sources: funding of study not described Conflicts of interest: study authors declare no conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization methods not described |
Allocation concealment (selection bias) | Unclear risk | Concealment of allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Sham block was used. Blinding of personnel not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Rate of attrition not described |
Selective reporting (reporting bias) | Unclear risk | Unclear if subgroup analysis was performed |
Null bias | High risk | Quote: "the incidence of pain... showed no difference between groups." |
5‐HT3: 5‐hydroxytryptamine; ANOVA: analysis of variance; ASA: American Society of Anesthesiology perioperative risk classification; BPI: brief pain inventory; EMLA: eutectic mixture of local anaesthetics; Epi: epinephrine; GA: general anaesthesia; h: hour; HRQOL: health‐related quality of life; ICBG: iliac crest bone graft harvesting; IM: intramuscular; ITM: intrathecal morphine; ITT: intention‐to‐treat; IV: intravenous; Kg: kilogram; L2: lumbar segment number 2; LA: local anaesthetic; LMA: laryngeal mask airway; MAC: minimum alveolar concentration; mg: milligram; mL: millilitre; NIH: National Institute of Health; NSAID: nonsteroidal anti‐inflammatory drugs; NRS: numerical rating scale; paracetamol: acetaminophen; PACU: postanaesthesia care unit; PCA: participant controlled analgesia; PCEA: patient controlled epidural analgesia; POD: postoperative day; PVB: paravertebral block; RCT: randomized controlled trial; SA: spinal anaesthesia; SAB: subarachnoid block; SC: subcutaneous; SD: standard deviation; SF‐36: Short Form (36) Health Survey; SF‐MPQ‐2: Short Form MacGill Pain Questionaire; T4: thoracic segment 4; TAP: transabdominal plane block; TEA: thoracic epidural analgesia; µg: microgram; VAS: visual analogue scale