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

NCT ID: NCT07094802

Last Updated: 2025-07-30

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-08-15

Brief Summary

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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

Detailed Description

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Conditions

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Postoperative Pain Cesarean Delivery Analgesia, Obstetrical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Morphine Group

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

Group Type ACTIVE_COMPARATOR

Intrathecal morphine with bupivacaine

Intervention Type DRUG

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

Bupivacaine Group

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

Group Type PLACEBO_COMPARATOR

Hyperbaric Bupivicaine

Intervention Type DRUG

0.5% hyperbaric Bupivacaine 2.2 ml

Interventions

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Intrathecal morphine with bupivacaine

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

Intervention Type DRUG

Hyperbaric Bupivicaine

0.5% hyperbaric Bupivacaine 2.2 ml

Intervention Type DRUG

Other Intervention Names

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morphine opioids intrathecal morphine Bupivacaine hyperbaric bupivacaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role lead

Responsible Party

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Megha Patrabansha

Dr., Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IT Morphine CS -072114

Identifier Type: -

Identifier Source: org_study_id

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