“…No report on the exact number of
participants with missing data at 6 or 12 months’ follow-up, only states ”The maximum percentage of
missing data for each point (0, 3, 6, and 12 months) in both arms was less than 5% (range: 0%-5%). ITT was
performed
Selective reporting (reporting bias) |
Low risk |
The primary and secondary outcomes listed in the protocol were all reported |
Null bias |
Low risk |
Quote: “measurement of pain on the VAS showed lower scores at rest and
during mobilization in the first 90 min after the end of surgery in the ropivacaine group than in the control
group (P < 0.001)... Ropivacaine wound infiltration decreased immediate postoperative pain in the PACU and
increased the percentage of pain-free patients (VAS = 0) for the first 48h” |
Barkhuysen 2010
|
Methods |
Double-blinded, clinical RCT Randomization scheme not
described Follow-up: 1 year |
Participants |
Participants: 200 adults in a hospital setting in Nijmegen,
Netherlands Operation: ICBG for cranio-maxillofacial surgery 2 groups, size: 100/100 Age
(range): 56 (21–74), 57 (21–80) Men/women: 25/31, 14/28 |
Interventions |
Group 1 (bupivacaine) : intraop: after wound closure,
participants received a single dose of bupivacaine (10 cc of 2.5 mg/mL bupivacaine with 1:80.000
epinephrine) Group 2 (control) : no intervention given Adjuvants:
epinephrine Immediate post-op pain control: no difference between VAS and post-op NSAID use between
groups |
Outcomes |
Dichotomous: pain/no pain questionnaire at 1 year Continuous:
none Other reported: use of paracetamol (Acetaminophen) and ibuprofen after surgery, duration of surgery,
blood loss, and length of incision Adverse events: perforation of the lateral cortex of the iliac crest,
haematoma |
Notes |
Financial support statement: “none.” Conflict of
interest statement: “none declared” |
Risk of bias
|
Bias
|
Authors’ judgement
|
Support for judgement
|
Random sequence generation (selection bias) |
Unclear risk |
Randomization scheme was not described |
Allocation concealment (selection bias) |
Low risk |
Quote: “for each patient an envelope was drawn” |
Blinding of participants and personnel (performance bias)... |
…”