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Active, Not Recruiting

NCT Number: NCT07419815

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaukat Khanam Memorial Cancer Hospital & Research Centre

Lahore, Punjab Province, 54470, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients allergic to lidocaine.
  • Patients refusal.
  • Patients having a history of chronic pain.
  • Patients already using opioids for pain control
  • Use of suxamethonium.
  • Procedures taking longer than 60 minutes

Treatment and study plan

Lidocaine infusion

Drug

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)

normal saline

Drug

patients in Group B will be given normal saline bolus and infusion at same rate during surgery

Primary outcomes

  1. Mean pain score

    Time frame: 2 hours

    Pain score using numeric rating scale (NRS) will be noted at arrival, 2 hours

Secondary outcomes

  1. Mean morphine consumption

    Time frame: till discharge from post anesthesia care unit

    Mean morphine consumption will be recorded in milligrams

Sponsors and collaborators

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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