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

Jain 2015.

Methods Randomized, controlled trial. No exact statement on blinding.
The aim of this study was to investigate whether IV perioperative lignocaine (bolus and infusion) would be able to produce both the effects simultaneously in elective laparoscopic cholecystectomies.
The study was conducted in India. Date not published.
Participants Number assessed for eligibility: N/A
Number randomized: 60→ 30:30
Number analysed: 60→ 30:30
Inclusion criteria
ASA I to II, age between 20 and 50 years and weighing between 40 and 70 kg, undergoing elective laparoscopic cholecystectomy (non‐malignant)
Exclusion criteria
cardio‐respiratory, renal, hepatic or endocrine disease, predicted difficult tracheal intubation;
whenever the surgical procedure necessitated the conversion of laparoscopic to open cholecystectomy or surgical time exceeded 180 min, patients were excluded from the study
Baseline details
Experimental group (n = 30)
Mean age (years): 34.97, SD = 11.06
M = 0%, F = 100%
Mean weight (kg): 53.90, SD = 9.06
ASA I/II (n): N/A
Mean duration of anaesthesia (min): N/A
Mean duration of surgery (min): 54.80, SD = 9.14
Main surgical procedures (n): laparoscopic cholecystectomy (30)
Control group (n = 30):
Mean age (years): 34.43, SD = 9.71
M = 0%, F = 100%
Mean weight (kg): 52, SD = 10.31
ASA I/II (n): N/A
Mean duration of anaesthesia (min): N/A
Mean duration of surgery (min): 53.37, SD = 8.47
Main surgical procedures (n): laparoscopic cholecystectomy (30)
Interventions Experimantal group (30 patients):
In Group Lidocaine, patients received ten min prior to induction preservative free lignocaine 2 % 1.5 mg/kg IV bolus (made to a volume of 6 ml with normal saline) administered over a period of 10 min and thereafter an infusion at a rate of 1.5 mg/kg/hr (pre‐diluted in normal saline made to a volume of 6 ml/hr). It was continued till the end of first post‐operative hour. The maximum duration of infusion was kept to 180 min (including 1 hr post‐operative infusion) as a safeguard against potential lignocaine toxicity.
Control group (30 patients)
Ten min prior to induction of anaesthesia patients received 6 ml normal saline as bolus over 10 min, followed by 6 ml/hr infusion. It was continued till the end of 1st post‐operative hour. The maximum duration of infusion was kept to 180 min (including 1 hr post‐operative infusion) as a safeguard against potential lignocaine toxicity.
Outcomes The primary endpoint of the study was MAP (mmHg).
Dichotomous

  1. Adverse events (drowsiness, perioral numbness, metallic taste)


Continuous

  1. Ketorolac requirement in 24 hrs (mg, mean + SD)

  2. Pentazocine requirement in 24 hrs (mg, mean + SD)

  3. Pulse rates (per min)

  4. MAP (mmHg)

  5. Pain free period (NRS < 4) in 24 hrs
Notes

  1. All female patients (100%) in both groups

  2. Small trial sample size (< 200 patients)

  3. Power analysis performed (MAP, n = 28 per group)

  4. Oral informed consent


Medication
All patients were premedicated with injection midazolam 0.025 mg/kg IV, injection ketorolac 0.5 mg/kg IM (maximum of 30 mg), and injection ondansetron 0.1 mg/kg IV. First dose of ketorolac 0.5 mg/kg (maximum 30 mg) IM was administered when the NRS ≥ 4 was reported by the patient. Subsequently, if NRS was ≥ 4, the patient received injection ketorolac IM 6 hourly. Despite administration of ketorolac, if patient reported NRS ≥ 4, then injection pentazocine 0.25 mg/kg was administered.
Anaesthesia
The anaesthesia regime was standardized in both groups.
Funding
N/A
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “the patients were randomly divided (by chit‐ in‐ a‐ box technique).”
There is insufficient information to decide whether this technique provided adequate randomization sequence.
Allocation concealment (selection bias) Unclear risk No statement on allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: “all the cases were done by same surgeon and anaesthesia given by the same team. […] Surgeon and the nursing staff in the recovery room were also blinded about the patient's group.”
It is not explicitly stated that the attending anaesthetist and the patient were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “data collection was done by a team member who was blinded to the group of patient.”
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There are no missing data.
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.