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Completed

NCT Number: NCT06191770

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

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

Completed

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Key information

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gauhar Afshan

Karachi, Sindh, 65200, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine,

Procedure

Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)

Other names: Nalbuphine

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

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

    Time frame: 1 year

    To assess the adverse events associated with nalbuphine and morphine.

Sponsors and collaborators

Lead sponsor

Aga Khan University Hospital, Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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