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

NCT07094802 — Phase 4, Not yet recruiting, 92 participants, Tribhuvan University Teaching Hospital, Institute Of Medicine.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07094802
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	92 (Estimated)
Sponsor	Tribhuvan University Teaching Hospital, Institute Of Medicine. (Other)
Conditions	Postoperative Pain, Cesarean Delivery, Analgesia, Obstetrical
Interventions	Intrathecal morphine with bupivacaine, Hyperbaric Bupivicaine (Drug)
Dates	start 2025-10-15 (estimated), primary completion 2026-03-20 (estimated), completion 2026-08-15 (estimated), first posted 2025-07-30, last updated 2025-07-30

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Morphine Group	Active comparator	Drug: Intrathecal morphine with bupivacaine	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
Bupivacaine Group	Placebo comparator	Drug: Hyperbaric Bupivicaine	This group will receive 2.2 ml of 0.5% hyperbaric bupivacaine during spinal anesthesia

Intrathecal morphine with bupivacaine (Drug), also known as morphine, opioids, intrathecal morphine: Participants will receive 100 mcg intrathecal morphine along with 2.2ml of 0.5% hyperbaric bupivacaine
Hyperbaric Bupivicaine (Drug), also known as Bupivacaine, hyperbaric bupivacaine: 0.5% hyperbaric Bupivacaine 2.2 ml

+Outcome measures

Primary outcomes

Time to need of first rescue analgesic [within 24 hours]: time of spinal anesthesia to time of demand of first rescue analgesic
NRS score [24 hours]: comapre NRS score at 0,1,6,12,18,24 hours between the groups

Secondary outcomes

24 hours analgesic consumption [24 hours]: consumtion of total analgesic in first 24 hours

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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