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. 2018 Jun 4;2018(6):CD009642. doi: 10.1002/14651858.CD009642.pub3

Lauwick 2009.

Methods Randomized, placebo‐controlled trial. No statement on blinding of participants and outcome assessors. The anaesthesiologists were blinded.
This study was performed to assess the effect of intra‐ and postoperative lidocaine infusion on postoperative functional walking capacity, as a measure of surgical recovery in patients undergoing laparoscopic prostatectomy.
The study was conducted in Canada from May 2007 to February 2008.
Participants Number assessed for eligibility: N/A
Number randomized: 40 → 20:20
Number analysed: 20:20
Inclusion criteria
Male patients undergoing laparoscopic prostatectomy.
Exclusion criteria
ASA physical status ≥ 4, history of hepatic, renal, or cardiac failure, organ transplant, insulin‐dependent diabetes mellitus, morbid obesity (BMI > 40 kg m²), chronic use of opioids, allergy to local anaesthetics, or inability to comprehend pain assessments.
Baseline details
Experimental group (n = 20)
Mean age (years): 60
M = 100%, F = 0%
Mean weight (kg): 79
ASA I/II/III: 5:14:1
Duration of surgery (min): 262.5
Main surgical procedure: laparoscopic prostatectomy
Control group (n = 20)
Mean age (years): 59
M = 100%, F = 0%
Mean weight (kg): 82
ASA I/II/III: 10:7:3
Duration of surgery (min): 240
Main surgical procedure: laparoscopic prostatectomy
Interventions Experimental group (20 patients)
At induction of anaesthesia, the lidocaine group received an i.v. bolus injection of lidocaine 1.5 mg/kg up to a maximum of 100 mg, followed by a continuous infusion of lidocaine 2 mg/kg/hr until the end of surgery.
Control group (20 patients)
Patients in the control group received an equivalent volume of saline 0.9%.
Outcomes The primary endpoint of the study was functional walking capacity.
Dichotomous
  1. Postoperative nausea and vomiting during 48 hrs after surgery

  2. Intraoperative complications (bleeding)

  3. Postoperative complications (bleeding, infection, bladder leak)

  4. Patients not using PCA on second postoperative 24 hrs

  5. Readmission


Continuous
  1. Pain score (VAS 0 to 10) during rest, walking, and coughing at POD 1 and POD 2 (individual group data were not presented)

  2. Fatigue score (VAS 0 to 10) at POD 1 and POD 2 (individual group data were not presented)

  3. 2‐minutes walking distance (2‐MWT), predicted, preoperative, POD 1, POD 2, and POD‐3, (data presented as median with IQR)

  4. Fentanyl consumption (µg), intraoperatively, (data presented as median with IQR)

  5. PCA morphine consumption 0 to 24 hrs, 24 to 48 hrs, 0 to 48 hrs, (data presented as median with IQR, in part with asymmetric distribution)

  6. Passage of flatus (hrs)

  7. Bowel movement (hrs)

  8. Time to first full diet (hrs), (data presented as median with IQR)

  9. Ready for discharge (days)

  10. Length of stay (days)

Notes
  1. All male patients

  2. Small trial sample size (< 200 patients)

  3. Power analysis performed (functional walking capacity, n = 20)


Medication
"PCA morphine (1 mg bolus, 7 min lockout) was started in PACU and continued for 48 hrs. Patients also received acetaminophen 1.0 g 6 hourly and naproxen 500 mg 12 hourly for the first 72 hrs. Once PCA morphine was discontinued, patients were offered oxycodone 5–10 mg 4 hourly if the VAS (0 = no pain and 10 = excruciating pain) was > 3 at rest. Ondansetron 2 mg i.v. was prescribed for persistent nausea (lasting > 5 min) or vomiting."
Anaesthesia
 The anaesthesia regime was standardized in both groups.
Funding
 "Dr S. Lauwick is a recipient of a clinical fellowship in anaesthesia for minimally invasive surgery from the Steinberg‐Bernstein Centre for Minimally Invasive Surgery and the Montreal General Hospital Foundation, and a clinical research grant from the CHU of LIEGE, Belgium. This work was supported by internal funds, Department of Anesthesia, McGill University Health Centre."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…patients were randomly assigned (using a computer‐generated randomization schedule…"
Allocation concealment (selection bias) Unclear risk Quote: "….sealed brown envelopes…" Not mentioned that envelopes were sequentially numbered.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "the anaesthesiologists (S.L. and F.C.) who executed the study protocol were blinded to the group allocation and were not involved in preoperative or postoperative data collection." No statement on blinding of participants and other personnel.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No statement on blinding of outcome assessors.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals. No exclusions.
Selective reporting (reporting bias) Unclear risk There is no reference to a trial registry and no published study protocol.
Other bias Low risk The study appears to be free of other sources of bias.