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

Not Applicable

Completed

• Conditions: Postoperative Pain; Cesarean Section
• Interventions: Drug: Fentanyl HCl; Drug: Bupivacaine 0.25% Injectable Solution

• Registration Number: NCT05550597
• Lead Sponsor: Nepal Mediciti Hospital

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.

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 Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Primary Completion: 2023-02-20
• Status Verified: 2023-03
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F	Fentanyl HCl	The intrathecal additive Fentanyl with hyperbaric bupivacaine
Group FT	Fentanyl HCl	The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
Group FT	Bupivacaine 0.25% Injectable Solution	The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block
Group T	Bupivacaine 0.25% Injectable Solution	Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Nepal Mediciti Hospital; 🇳🇵 Lalitpur, Nepal