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Not yet recruiting NCT07094802

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

Phase IV Interventional Postoperative Pain Cesarean Delivery Analgesia, Obstetrical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intrathecal morphine with bupivacaine, Hyperbaric Bupivicaine.
Who it may be relevant to
Registry conditions: Postoperative Pain, Cesarean Delivery, Analgesia, Obstetrical. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Drug Intrathecal morphine with bupivacaine
    Participants will receive 100 mcg intrathecal morphine along with 2.2ml of 0.5% hyperbaric bupivacaine
  • Drug Hyperbaric Bupivicaine
    0.5% hyperbaric Bupivacaine 2.2 ml

Primary outcome measures

  • Time to need of first rescue analgesic [Time frame: within 24 hours]
  • NRS score [Time frame: 24 hours]
Secondary outcome measures (1)
  • 24 hours analgesic consumption [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07094802 · IT Morphine CS -072114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗