Procedural PainNCT07422558
Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain
A study testing Nalbuphine and Lidocaine in people with Procedural Pain, run by Hayatabad Medical Complex.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Nalbuphine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- Either male or female
- ASA physical status I or II
- Scheduled for elective general surgery under general anesthesia using propofol
Who cannot join
- Known hypersensitivity to propofol, nalbuphine, or lidocaine
- Emergency surgery
- Use of analgesics prior to surgery
- Pregnant women
- Lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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
- Conditions
- Procedural Pain
- Being tested
- Nalbuphine, Lidocaine
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Intravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol
LidocaineDrug
Intravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol
| Study group | Role | What they receive |
|---|---|---|
| Nalbupine group | Experimental | Patient recieving intravenous nalbuphine prior to propofol induction Receives: Drug: Nalbuphine |
| Lidocaine group | Active comparator | Patient recieving intravenous lidocaine prior to propofol induction Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During induction of anesthesia (within 1-2 minutes of propofol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amina Sultan, Hayatabad Medical Complex
- Investigators
- Dr.Arina kore Trainee medical officer, MBBS, Principal investigator, PGMI/Hayatabad Medical complex(HMC),Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422558
- Sponsor's protocol ID
- ANA-PROP-01
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and instituional policies
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprasion of Intravenous Nalbuphine Versus Lidocaine in Reducing Propofol -Induced Injection Pain During General Surgery Procedure
- ClinicalTrials.gov ID
- NCT07422558
- Acronym / sponsor ID
- ANA-PROP-01
- Conditions
- Procedural Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalbupine group | Experimental | Drug: NalbuphinePatient recieving intravenous nalbuphine prior to propofol induction |
| Lidocaine group | Active comparator | Drug: LidocainePatient recieving intravenous lidocaine prior to propofol induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
Key exclusion criteria (5 listed)
- Known hypersensitivity to propofol, nalbuphine, or lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NalbuphineIntravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol | Drug | Nalbupine group |
| LidocaineIntravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol | Drug | Lidocaine group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and instituional policies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.Arina kore Trainee medical officer, MBBS principal investigator
PGMI/Hayatabad Medical complex(HMC),Peshawar
Questions about this trial
What is this clinical trial studying?
A study testing Nalbuphine and Lidocaine in people with Procedural Pain, run by Hayatabad Medical Complex.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Arina kore Trainee medical officer, MBBS (+923446835431, Kore2k15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of propofol- induced injection pain (time frame: During induction of anesthesia (within 1-2 minutes of propofol administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.