Comparison of Intrathecal Bupivacaine With and Without Morphine for Post-operative Analgesia in Parturients Undergoing Elective Cesarean Section: A Randomized Controlled Trial

The goal of this clinical trial is to compare intrathecal bupivacaine with or without morphine for postoperative analgesia in patients undergoing elective cesarean section. The main questions it aims to answer are:

Is intrathecal bupivacaine with morphine superior to intrathecal bupivacaine alone for postoperative analgesia for parturients undergoing cesarean section? What is the duration of analgesia in the two groups? Researchers will compare drug intrathecal bupivacaine with morphine to a iintrathecal bupivacaine alone to see if intrathecal morphine has benefits for psotoperative analgesia .

Participants will:

Get intrathecal bupivacaine with Morphine or intrathecal bupivacaine alone during spinal anesthesia for cesarean section.

They will be followed up for NRS pain scores and side effects for 24 hours. Time to need of first rescue analgesic will be noted

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Key information

Conditions

Postoperative Pain Agnosia Analgesia, Obstetrical Cesarean Delivery Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Parturients undergoing elective caesarean section under Spinal anesthesia
ASA PS II, III
> 18 years

Exclusion criteria

Refusal to Participate
Contraindications to spinal anaesthesia and adjuvants INR ≥ 1.5 Plateletes < 1,00,000/cumm Severe aortic stenosis, and/or severe mitral stenosis Infection at lumbar puncture site Known allergy to local anesthetics and opioids
Communication barrier
Height <150 cm

Treatment and study plan

Intrathecal morphine with bupivacaine

Drug

Participants will receive 100 mcg intrathecal morphine along with 2.2ml of 0.5% hyperbaric bupivacaine

Other names: morphine, opioids, intrathecal morphine

Hyperbaric Bupivicaine

Drug

0.5% hyperbaric Bupivacaine 2.2 ml

Other names: Bupivacaine, hyperbaric bupivacaine

Primary outcomes

Time to need of first rescue analgesic

Time frame: within 24 hours

time of spinal anesthesia to time of demand of first rescue analgesic
NRS score

Time frame: 24 hours

comapre NRS score at 0,1,6,12,18,24 hours between the groups

Secondary outcomes

24 hours analgesic consumption

Time frame: 24 hours

consumtion of total analgesic in first 24 hours

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 30, 2025
Registry last updated: Jul 30, 2025

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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Completed