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

NCT06191770 | Completed DMC

• 1 other identifier: 2018-0209-414
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

Morphine Arm

ACTIVE COMPARATOR

NRS score used

Procedure: Morphine,

Nalbuphine Arm

ACTIVE COMPARATOR

Both Groups

Procedure: Morphine,

Interventions

Morphine, PROCEDURE

Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)

Also known as: Nalbuphine

Morphine Arm; Nalbuphine Arm

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: Only Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Gauhar Afshan

Karachi, Sindh, 65200, Pakistan

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Morphine; Nalbuphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind Clinical Trial, CTU prepare the Medications, and Patient, investigator and Data Collector was completely blind to the Stuidy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BAL CHAND

Model Details: Two groups

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: October 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: Anyone

Locations

PA (1)