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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-10-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind Clinical Trial, CTU prepare the Medications, and Patient, investigator and Data Collector was completely blind to the Stuidy

Study Groups

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Morphine Arm

NRS score used

Group Type ACTIVE_COMPARATOR

Morphine,

Intervention Type PROCEDURE

Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)

Nalbuphine Arm

Both Groups

Group Type ACTIVE_COMPARATOR

Morphine,

Intervention Type PROCEDURE

Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)

Interventions

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Morphine,

Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)

Intervention Type PROCEDURE

Other Intervention Names

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Nalbuphine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No