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NCT Number: NCT07422558

Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Nalbuphine

Drug

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

Lidocaine

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Arina kore Trainee medical officer, MBBS

CONTACT

[email protected]

+923446835431

Sponsors and collaborators

Lead sponsor

Hayatabad Medical Complex

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 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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