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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-03-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Pain Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group F

The intrathecal additive Fentanyl with hyperbaric bupivacaine

Group Type EXPERIMENTAL

Fentanyl HCl

Intervention Type DRUG

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Group FT

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

Group Type EXPERIMENTAL

Fentanyl HCl

Intervention Type DRUG

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution

Group T

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

Group Type EXPERIMENTAL

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution

Interventions

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Fentanyl HCl

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Intrathecal Fentanyl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No