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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cesarean Section
• Intervention / Treatment: Drug: Fentanyl HCl; Drug: Bupivacaine 0.25% Injectable Solution

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Lalitpur, Nepal
    • Nepal Mediciti Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the time to the first rescue analgesics	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	Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nepal Mediciti Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: 2022 (CN Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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