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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07419815
Enrollment
62
Registered
2026-02-19
Start date
2025-12-03
Completion date
2026-08-30
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Side Effects of Opoid Consumption

Keywords

mean pain score, acute pain, mean morphine consumption

Brief 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.

Interventions

DRUGLidocaine 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)

DRUGNormal Saline

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

Sponsors

Shaukat Khanum Memorial Cancer Hospital & Research Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Intervention model description

Randomized controlled trial. One group will recieve lidocaine infusion and other group will reciev placebo. option of rescue analgesia will be given to both groups if needed.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean pain score2 hoursPain score using numeric rating scale will be noted at arrival, 2 hours

Secondary

MeasureTime frameDescription
Mean morphine consumption2 hours post operativelyMean morphine consumption will be recorded in milligrams

Countries

Pakistan

Contacts

STUDY_CHAIRDr. Almas Iqbal, MBBS, MBA, FRCA

Shaukat Khanam Memorial Cancer Hospital & Research Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026