Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain

February 13, 2026 updated by: Amina Sultan, Hayatabad Medical Complex

Comprasion of Intravenous Nalbuphine Versus Lidocaine in Reducing Propofol -Induced Injection Pain During General Surgery Procedure

Propofol is a commonly used intravenous anesthetic agent, but its administration is frequently associated with injection pain, causing patient discomfort and agitation. Various pharmacological agents have been used to reduce this pain, including nalbuphine and lidocaine; however, results from previous studies remain conflicting. This randomized clinical trial aims to compare the effectiveness of intravenous nalbuphine versus intravenous lidocaine in reducing the frequency of propofol-induced injection pain in patients undergoing elective general surgery procedures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Propofol-induced injection pain is a common and undesirable adverse effect that can lead to patient distress during induction of anesthesia. Nalbuphine, a kappa-opioid receptor agonist and partial mu-opioid receptor antagonist, and lidocaine, a sodium channel blocker, have both been used to reduce this pain, but evidence regarding their comparative effectiveness remains inconsistent.

This randomized clinical trial will be conducted in the Department of Anesthesiology, PGMI / Hayatabad Medical Complex, Peshawar. A total of 92 adult patients with ASA physical status I-II, scheduled for elective general surgery under general anesthesia, will be enrolled and randomized into two equal groups. Group A will receive intravenous nalbuphine at a dose of 0.1 mg/kg, while Group B will receive intravenous lidocaine at a dose of 4.5 mg/kg (maximum 300 mg), administered 60 seconds prior to induction with propofol. Injection pain will be assessed by the inducing anesthesiologist using a four-point pai

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr.Arina kore Trainee medical officer, MBBS
  • Phone Number: +923446835431
  • Email: Kore2k15@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-60 years

    • Either male or female
    • ASA physical status I or II
    • Scheduled for elective general surgery under general anesthesia using propofol

Exclusion Criteria:

  • Known hypersensitivity to propofol, nalbuphine, or lidocaine

    • Emergency surgery
    • Use of analgesics prior to surgery
    • Pregnant women
    • Lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalbupine group
Patient recieving intravenous nalbuphine prior to propofol induction
Drug: Nalbuphine
Intravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol
Active Comparator: Lidocaine group
Patient recieving intravenous lidocaine prior to propofol induction
Drug: Lidocaine
Intravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of propofol- induced injection pain
Time Frame: During induction of anesthesia (within 1-2 minutes of propofol administration
Presence of injection pain assessed using a four-point pain scale during propofol injection until loss of eyelash reflex. Pain score ≥1 will be considered as presence of injection pain.
During induction of anesthesia (within 1-2 minutes of propofol administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayatabad Medical Complex

Investigators

  • Principal Investigator: Dr.Arina kore Trainee medical officer, MBBS, PGMI/Hayatabad Medical complex(HMC),Peshawar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-PROP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient confidentiality and instituional policies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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