Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine

Phase 1

Completed

• Conditions: Post Operative Pain; Cesarean Section Pain
• Interventions: Drug: NSAID , NALUFIN , local anesthetic andTAP Block

• Registration Number: NCT05276206
• Lead Sponsor: Egymedicalpedia

Brief Summary

Approximately 1 in 5 women who undergo CS will experience severe acute postoperative pain. The severity of pain in the acute postoperative period is a significant predictor for the development of chronic pain, which occurs in 9.2%-18% of women who undergo CS. Furthermore, severe acute post-cesarean pain triples a woman's risk of developing postpartum depression and negatively affects breastfeeding and infant care. For these reasons, it is imperative to provide adequate postoperative analgesia in this patient population

Detailed Description

Local wound infiltration is an attractive strategy since it is efficacious and side effects are minimal. Nowadays, there is a trend toward preferring ropivacaine over other local anesthetic agents due to the longer duration of action and better safety profile. Local anesthetic infiltration, however, has a limitation in that pain relief is offered till the effects of local anesthetic action lasts. Efforts are being made to prolong the duration of action of local anesthetic skin infiltration, and dexmedetomidine is one such agent which can potentiate and prolong the duration of local anesthetic wound infiltration for pain relief.

A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within the fascial plane between the transversus abdominis and internal oblique muscles: bilateral block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then injected between the internal oblique and transverse abdominis muscles just deep the fascial plane, the plane through which the sensory nerves pass

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-03-02
• Study Start: 2022-03-07
• Study First Posted: 2022-03-11
• Primary Completion: 2022-03-20
• Study Completion: 2022-04-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pregnant women aged 20-35 years
• Gestational age between 37-40 weeks
• Pregnant women undergoing elective cesarean section
• Medically free
• Singleton pregnancy

Exclusion Criteria

• Emergency cesarean section
• Diabetic
• Hypertensive
• Severe anemia
• Multiple pregnancy
• Complication during section

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
NSAID	NSAID , NALUFIN , local anesthetic andTAP Block	The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need
local anesthetic group	NSAID , NALUFIN , local anesthetic andTAP Block	the local anesthetic group will be given a S.C injection of local anesthetic in the wound
TAP block	NSAID , NALUFIN , local anesthetic andTAP Block	Total abdominal plain block group will be given a TAP block
Nalufin	NSAID , NALUFIN , local anesthetic andTAP Block	group will be given IV nalufin

Primary Outcome Measures

Name	Time	Method
Post Operative Pain	2 hours after the Cesarean Section till the pain relief	The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt