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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTribhuvan University Teaching Hospital, Institute Of Medicine.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Parturients undergoing elective caesarean section under Spinal anesthesia

ASA PS II, III

> 18 years

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intrathecal morphine with bupivacaine

    Drug

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

  • Hyperbaric Bupivicaine

    Drug

    0.5% hyperbaric Bupivacaine 2.2 ml

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Morphine GroupActive comparator 1 intervention
Group B: Bupivacaine GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to need of first rescue analgesic

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

Time frame
within 24 hours
2

NRS score

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

Time frame
24 hours

Secondary outcomes

1

24 hours analgesic consumption

consumtion of total analgesic in first 24 hours

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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