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

Nepal Mediciti Hospital

Status: Completed

Conditions: Postoperative Pain; Cesarean Section

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05550597

2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Group F

Experimental group

Description:

The intrathecal additive Fentanyl with hyperbaric bupivacaine

Treatment:

Drug: Fentanyl HCl

Group FT

Experimental group

Description:

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

Treatment:

Drug: Fentanyl HCl

Drug: Bupivacaine 0.25% Injectable Solution

Group T

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine 0.25% Injectable Solution