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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Side Effects of Opoid Consumption
• Intervention / Treatment: Drug: Lidocaine Infusion; Drug: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54470
      • Shaukat Khanam Memorial Cancer Hospital & Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 to 60 years.
2. American Society of Anesthesiologists grade 1 and 2 patients.
3. Both Genders
4. Elective staging Laparoscopy

Exclusion Criteria:

1. Patients allergic to lidocaine.
2. Patients refusal.
3. Patients having a history of chronic pain.
4. Patients already using opioids for pain control
5. Use of suxamethonium.
6. Procedures taking longer than 60 minutes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; This arm will receive Lidocaine infusion	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)
Placebo Comparator: Group B; This arm will receive placebo	Drug: Normal Saline; patients in Group B will be given normal saline bolus and infusion at same rate during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain score	Pain score using numeric rating scale (NRS) will be noted at arrival, 2 hours	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean morphine consumption	Mean morphine consumption will be recorded in milligrams	till discharge from post anesthesia care unit

Collaborators and Investigators

• Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
• Investigators: Study Chair: Dr. Almas Iqbal, MBBS, MBA, FRCA, Shaukat Khanam Memorial Cancer Hospital & Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: acute pain; mean pain score; mean morphine consumption
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: IRB-24-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No