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

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Pain; Analgesia, Obstetrical; Cesarean Delivery

Treatments: Drug: Intrathecal morphine with bupivacaine; Drug: Hyperbaric Bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07094802

IT Morphine CS -072114

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

92 participants in 2 patient groups, including a placebo group

Morphine Group

Active Comparator group

Description:

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

Treatment:

Drug: Intrathecal morphine with bupivacaine

Bupivacaine Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Hyperbaric Bupivicaine