ClinicalTrials.gg
Not yet recruitingNCT07422558Updated Feb 20, 2026

Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain

An interventional study of Nalbuphine and Lidocaine in Procedural Pain, sponsored by Hayatabad Medical Complex. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by Hayatabad Medical Complex · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Procedural Pain

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03

In context

Pain, Procedural

241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's planned enrollment of 92 is close to the median of 90 across 227 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

Hayatabad Medical Complex is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-60 years

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

Exclusion criteria

Exclusion Criteria:

  • Known to propofol, nalbuphine, or lidocaine

    • Emergency surgery
    • Use of analgesics prior to surgery
    • Pregnant women
    • Lactating women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Nalbupine group

    Patient recieving intravenous nalbuphine prior to propofol induction

    Drug: Nalbuphine

  • Active comparator
    Lidocaine group

    Patient recieving intravenous lidocaine prior to propofol induction

    Drug: Lidocaine

Interventions

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

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

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What researchers measure

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.

    Time frame: During induction of anesthesia (within 1-2 minutes of propofol administration

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to patient confidentiality and instituional policies

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07422558
Lead sponsor
Hayatabad Medical Complex
Responsible party
Amina Sultan (Assistant professor, Hayatabad Medical Complex) — Principal investigator
First posted
Feb 20, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Feb 20, 2026

Study contacts

Dr.Arina kore Trainee medical officer, MBBS
Contact
Kore2k15@gmail.com
+923446835431
Dr.Arina kore Trainee medical officer, MBBS
principal investigator · PGMI/Hayatabad Medical complex(HMC),Peshawar

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Nalbuphine

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