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Clinical Trials/NCT05186454
NCT05186454
Unknown
Phase 2

Multimodal Intrathecal Analgesia for Cesarean Section

Sohag University1 site in 1 country60 target enrollmentMay 23, 2021

Overview

Phase
Phase 2
Intervention
Bupivacaine
Conditions
Post Operative Pain
Sponsor
Sohag University
Enrollment
60
Locations
1
Primary Endpoint
1st analgesic requirement
Last Updated
4 years ago

Overview

Brief Summary

Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.

Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine

Registry
clinicaltrials.gov
Start Date
May 23, 2021
End Date
February 15, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fouad Soliman

Lecturer of Anesthesia and ICU

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Morphine

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.

Intervention: Bupivacaine

Morphine

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.

Intervention: Morphine Sulfate

Multimodal

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally

Intervention: Bupivacaine

Multimodal

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally

Intervention: dexamethasone, morphine, midazolam

Outcomes

Primary Outcomes

1st analgesic requirement

Time Frame: 24 hours

The first time of supplemental analgesic need postoperatively

Secondary Outcomes

  • Analgesic consumption(24 hours)
  • Post operative pain(24 hours)
  • Side effects(24 hours)

Study Sites (1)

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