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

NCT07094802 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IT Morphine CS -072114
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain; Cesarean Delivery; Analgesia, Obstetrical

Outcome Measures

Primary Outcomes (2)

• Time to need of first rescue analgesic

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

  within 24 hours

• NRS score

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

  24 hours

Secondary Outcomes (1)

• 24 hours analgesic consumption

  24 hours

Study Arms (2)

Morphine Group

ACTIVE COMPARATOR

This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine + 100 mcg (0.1 ml of 1 mg/ml) Morphine intrathecally during spinal anesthesia

Drug: Intrathecal morphine with bupivacaine

Bupivacaine Group

PLACEBO COMPARATOR

This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine during spinal anesthesia

Drug: Hyperbaric Bupivicaine

Interventions

Intrathecal morphine with bupivacaine DRUG

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

Also known as: morphine, opioids, intrathecal morphine

Morphine Group

Hyperbaric Bupivicaine DRUG

0.5% hyperbaric Bupivacaine 2.2 ml

Also known as: Bupivacaine, hyperbaric bupivacaine

Bupivacaine Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Morphine; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; 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; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Resident

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: October 15, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07