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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

Primary Purpose

Postoperative Pain, Cesarean Section

Status

Completed

Phase

Not Applicable

Locations

Nepal

Study Type

Interventional

Intervention

Fentanyl HCl

Bupivacaine 0.25% Injectable Solution

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Nepal Mediciti Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group F

Group FT

Group T

Arm Description

The intrathecal additive Fentanyl with hyperbaric bupivacaine

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05550597

First Posted

September 13, 2022

Last Updated

March 24, 2023

Sponsor

Nepal Mediciti Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05550597

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

February 20, 2023 (Actual)

Study Completion Date

March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nepal Mediciti Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Cesarean Section

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group F

Arm Type

Experimental

Arm Description

The intrathecal additive Fentanyl with hyperbaric bupivacaine

Arm Title

Group FT

Arm Type

Experimental

Arm Description

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

Arm Title

Group T

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fentanyl HCl

Intervention Description

Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia

Intervention Type

Drug

Intervention Name(s)

Bupivacaine 0.25% Injectable Solution

Other Intervention Name(s)

Intrathecal Fentanyl

Intervention Description

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

Primary Outcome Measure Information:

Title

To compare the time to the first rescue analgesics

Description

Time Frame

Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bijay Rayamajhi, FCPS

Organizational Affiliation

Nepal Mediciti Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nepal Mediciti Hospital

City

Lalitpur

Country

Nepal

12. IPD Sharing Statement

Plan to Share IPD

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