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

N/ACompletedNCT06191770

Aga Khan University Hospital, Pakistan66 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Acute

Interventions

Morphine,PROCEDURE

Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (1)

Gauhar Afshan

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Morphine Versus Nalbuphine in a multimodal Analgesia for Patients undergoing Gynecological Procedures: A double blind randomized controlled trial

The primary objective was to compare the analgesic requirement of morphine with nalbuphine in multimodal approach (with Paracetamol and Ketamine).

Time frame: 1 year

Secondary Outcomes

Morphine Versus Nalbuphine in a multimodal Analgesia for Patients undergoing Gynecological Procedures: A double blind randomized controlled trial

To assess the adverse events associated with nalbuphine and morphine.

Time frame: 1 year

Data from ClinicalTrials.gov

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