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

NCT05550597 | Completed

• 1 other identifier: 2022
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (3)

Group F

EXPERIMENTAL

The intrathecal additive Fentanyl with hyperbaric bupivacaine

Drug: Fentanyl HCl

Group FT

EXPERIMENTAL

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

Drug: Fentanyl HCl; Drug: Bupivacaine 0.25% Injectable Solution

Group T

EXPERIMENTAL

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

Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Fentanyl HCl DRUG

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Group F; Group FT

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

Also known as: Intrathecal Fentanyl

Group FT; Group T

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nepal Mediciti Hospital: lead

Study Sites (1)

Nepal Mediciti Hospital

Lalitpur, Nepal

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bijay Rayamajhi, FCPS

  Nepal Mediciti Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Resident

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: August 15, 2022
• Primary Completion: February 20, 2023
• Study Completion: March 15, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)