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NCT Number: NCT05550597

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

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.

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Key information

Conditions

Postoperative Pain Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nepal Mediciti Hospital

Lalitpur, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl HCl

Drug

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Bupivacaine 0.25% Injectable Solution

Drug

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

Primary outcomes

  1. To compare the time to the first rescue analgesics

    Time frame: 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 outcomes

  1. Percentage of participants with treatment related side effects like pruritus, nausea and vomiting.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nepal Mediciti Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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