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

A

Aga Khan University Hospital, Pakistan

Status

Completed

Conditions

Pain, Acute

Treatments

Procedure: Morphine,

Study type

Interventional

Funder types

Other

Identifiers

NCT06191770
2018-0209-414

Details and patient eligibility

About

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

Full 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

Enrollment

66 patients

Sex

Female

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 2 patient groups

Morphine Arm
Active Comparator group
Description:
NRS score used
Treatment:
Procedure: Morphine,
Nalbuphine Arm
Active Comparator group
Description:
Both Groups
Treatment:
Procedure: Morphine,

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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