NCT07422558

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 13, 2026

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of propofol- induced injection pain

    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

Study Arms (2)

Nalbupine group

EXPERIMENTAL

Patient recieving intravenous nalbuphine prior to propofol induction

Drug: Nalbuphine

Lidocaine group

ACTIVE COMPARATOR

Patient recieving intravenous lidocaine prior to propofol induction

Drug: Lidocaine

Interventions

Intravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol

Nalbupine group

Intravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol

Lidocaine group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Either male or female
  • ASA physical status I or II
  • Scheduled for elective general surgery under general anesthesia using propofol

You may not qualify if:

  • Known hypersensitivity to propofol, nalbuphine, or lidocaine
  • Emergency surgery
  • Use of analgesics prior to surgery
  • Pregnant women
  • Lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pain, Procedural

Interventions

NalbuphineLidocaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dr.Arina kore Trainee medical officer, MBBS

    PGMI/Hayatabad Medical complex(HMC),Peshawar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Arina kore Trainee medical officer, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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