Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

Sponsor
Nepal Mediciti Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05550597
Collaborator
(none)
93
1
3
5.6
16.7

Study Details

Study Description

Brief Summary

The postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided TAP block.

Investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under hyperbaric bupivacaine spinal anesthesia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fentanyl HCl
  • Drug: Bupivacaine 0.25% Injectable Solution
N/A

Detailed Description

Investigators will enroll 93 parturients planned for elective CS under hyperbaric bupivacaine spinal anesthesia and allocate them into three groups comprising intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone.

The primary outcome will be time to the first rescue analgesics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Time to the First Rescue Analgesic Among Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia
Actual Study Start Date :
Aug 16, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group F

The intrathecal additive Fentanyl with hyperbaric bupivacaine

Drug: Fentanyl HCl
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Experimental: Group FT

The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block

Drug: Fentanyl HCl
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Drug: Bupivacaine 0.25% Injectable Solution
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution
Other Names:
  • Intrathecal Fentanyl
  • Experimental: Group T

    Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl

    Drug: Bupivacaine 0.25% Injectable Solution
    Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution
    Other Names:
  • Intrathecal Fentanyl
  • Outcome Measures

    Primary Outcome Measures

    1. To compare the time to the first rescue analgesics [Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours]

      The time from the arrival to Postoperative care Unit to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

    Secondary Outcome Measures

    1. Percentage of participants with treatment related side effects like pruritus, nausea and vomiting. [Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours]

      To compare the side effects like pruritus, nausea and vomiting Among Parturients among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • American Society of Anesthesiology(ASA) physical status II

    • Able to read and understand the information sheet and to sign and date the consent form

    • Scheduled for elective CS planned with Spinal anesthesia

    • Gestational age > 37 weeks and < weeks assessed on the dating scale.

    Exclusion Criteria:
    • Complicated pregnancy; defined as having preeclampsia or placenta accreta,increta and percreta

    • Opioid addiction or dependence

    • Contraindications to TAP block( Ski infection, abdominal wall muscle defects)

    • Allergy to any medications used in the study

    • Case converted to General Anesthesia

    • Cases who develop postoperative hemorrhage, amniotic fluid embolism

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nepal Mediciti Hospital Lalitpur Nepal

    Sponsors and Collaborators

    • Nepal Mediciti Hospital

    Investigators

    • Principal Investigator: Bijay Rayamajhi, FCPS, Nepal Mediciti Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bijay Rayamajhi, Anesthesia Resident, Nepal Mediciti Hospital
    ClinicalTrials.gov Identifier:
    NCT05550597
    Other Study ID Numbers:
    • 2022
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Sep 22, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2022