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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07094802
Enrollment
92
Registered
2025-07-30
Start date
2025-10-15
Completion date
2026-08-15
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Obstetrical, Cesarean Delivery, Postoperative Pain

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

Interventions

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

0.5% hyperbaric Bupivacaine 2.2 ml

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to need of first rescue analgesicwithin 24 hourstime of spinal anesthesia to time of demand of first rescue analgesic
NRS score24 hourscomapre NRS score at 0,1,6,12,18,24 hours between the groups

Secondary

MeasureTime frameDescription
24 hours analgesic consumption24 hoursconsumtion of total analgesic in first 24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026