NCT07419815

IV Lidocaine Infusion Versus Placebo for Pain Control in Staging Laparoscopy Cases

Intravenous Lidocaine Infusion Versus Placebo, for Post Operative Acute Pain Control in Patients Undergoing Staging Laparoscopy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

IV lidocaine infusion is being used as an analgesic adjunct, since we are a opioid depleted country we are using lidocaine to decrease opioid consumption and avoid the side effects such nausea, vomiting and respiratory depression associated with morphine consumption. We have given the option of rescue analgesia to the anesthetist if the clinical scenario demands.

Detailed description

Total of 62 patients with 31 in each group will be selected after approval from Scientific Review Committee and Institutional review board. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either into group A (IV lidocaine) or group B (saline infusion). Lidocaine will be prepared in 50 ml syringes having concentration of 4mg per ml. All lidocaine and placebo administration in our patients will be through syringe pump having 50 cc syringes. Patients in Group A will be given intravenous lidocaine (2.0 %) first as a bolus of 1mg/kg over 3 minutes before incision and then as a continuous infusion of 2mg/kg/hour (maximum dose 200mg/hour), while patients in Group B will be given normal saline bolus and infusion at same rate during surgery. The infusion will be stopped when surgeons start closing the incision. Operations taking more than 60 minutes will be excluded from the final conclusion of results to prevent drug dose related confounding. Drug syringes for both the groups will be prepared by the researcher with the anesthetist and nurses being blind to the groups. In both group of patient's induction of anesthesia will be done using titrated dose of propofol, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg to blunt intubation response. Both group of patients will receive intravenous paracetamol 20mg/kg (maximum dose 1 gram) and diclofenac 75 mg (excluding the patients having contra indications to NSAID administration. At the end of procedure patients will be shifted to post anesthesia care unit and observed for pain. The anesthetist at his/her own discretion can use a total of 0.05-0.1 mg/kg dose of morphine given intravenously to control pain intraoperatively Pain score using numeric rating scale (NRS) will be noted at arrival, 2 hours and 4 hours post operatively. Rescue analgesia, intra venous morphine (0.1 mg/kg) will be administered if pain score is greater than \>3 in recovery area Data will be recorded on a Performa attached at the end.

Conditions

• Side Effects of Opoid Consumption

Interventions

Type	Name	Description
DRUG	Lidocaine Infusion	Patients in Group A will be given intravenous lidocaine (2.0 %) first as a bolus of 1mg/kg over 3 minutes before incision and then as a continuous infusion of 2mg/kg/hour (maximum dose 200mg/hour)
DRUG	Normal Saline	patients in Group B will be given normal saline bolus and infusion at same rate during surgery

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-06-30
• Completion: 2026-08-30
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Pakistan