Procedural Pain
Conditions
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.
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
Interventions
DRUGNalbuphine
Intravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol
DRUGLidocaine
Intravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol
Sponsors
Hayatabad Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of propofol- induced injection pain | 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. |
Contacts
CONTACTDr.Arina kore Trainee medical officer, MBBS
PRINCIPAL_INVESTIGATORDr.Arina kore Trainee medical officer, MBBS
PGMI/Hayatabad Medical complex(HMC),Peshawar
Outcome results
None listed