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

Postoperative Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05550597
• Other study ID #: 2022
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Nepal Mediciti Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 15, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Fentanyl HCl
Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia
• 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

Locations

Country	Name	City	State
Nepal	Nepal Mediciti Hospital	Lalitpur

Sponsors (1)

Lead Sponsor	Collaborator
Nepal Mediciti Hospital

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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