Comparison of Morphine With Nalbuphine in a Multimodal Approach for Pain Relief in Patients Undergoing Gynecological Procedures: Randomized Controlled Double Blind Clinical Trial

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Procedure: Morphine,

• Registration Number: NCT06191770
• Lead Sponsor: Aga Khan University Hospital, Pakistan

Brief Summary

This study was conducted in the Aga Khan University Hospital, Karachi. Pakistan is developing country and overall shortage of Morphine in developing country.

Rationalizing, in multimodal analgesia, Nalbuphine is equivalent to morphine in open Abdominal hysterectomy

Detailed Description

A large number of patients undergoing major surgical procedures need gold standard analgesic like morphine for adequate pain control. Shortage of Morphine results in inadequate pain relief leading to delayed recovery, prolonged hospitalization and persistent post-surgical pain syndrome.

For better surgical outcome, there is a strong need to find an alternative to morphine in a multi modal analgesia that help optimize pain relief with less opioids in patients undergoing gynecological procedures

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• All ASA I and ASA II women, age b/w 18-59 scheduled for Elective open moderate to major gynecological procedures at Aga Khan University Hospital

Exclusion Criteria

• Patient is unwilling to participate or provide informed consent History of chronic pain or pain syndrome with concurrent opioid medication use Fibromyalgia Patient has received opioids and/or tramadol in the past 4 hours History of adverse reaction to morphine, ketamine and nalbuphine Presence of oxygen dependent pulmonary disease, liver cirrhosis or renal disease requiring dialysis.

Presence of Ischemic heart disease Presence of intracranial mass or vascular lesion. Presence of psychosis or hallucinations Weight greater than 115kg or less than 45 kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nalbuphine Arm	Morphine,	Both Groups
Morphine Arm	Morphine,	NRS score used

Primary Outcome Measures

Name	Time	Method
Morphine Versus Nalbuphine in a multimodal Analgesia for Patients undergoing Gynecological Procedures: A double blind randomized controlled trial	1 year	The primary objective was to compare the analgesic requirement of morphine with nalbuphine in multimodal approach (with Paracetamol and Ketamine).

Secondary Outcome Measures

Name	Time	Method
Morphine Versus Nalbuphine in a multimodal Analgesia for Patients undergoing Gynecological Procedures: A double blind randomized controlled trial	1 year	To assess the adverse events associated with nalbuphine and morphine.

Trial Locations

Locations (1)

Gauhar Afshan; 🇵🇰 Karachi, Sindh, Pakistan