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

Comparative Study Between Transversus Abdominus Plain Block, Local Subcutaneous Injection in the Wound, and Intravenous Nalbuphine in Decreasing Postoperative Pain in Cesarean Section

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

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Cesarean Section Pain
• Intervention / Treatment: Drug: NSAID , NALUFIN , local anesthetic andTAP Block

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NSAID; The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need	Drug: NSAID , NALUFIN , local anesthetic andTAP Block; 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 and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present. In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared
Active Comparator: Nalufin; group will be given IV nalufin	Drug: NSAID , NALUFIN , local anesthetic andTAP Block; 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 and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present. In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared
Active Comparator: local anesthetic group; the local anesthetic group will be given a S.C injection of local anesthetic in the wound	Drug: NSAID , NALUFIN , local anesthetic andTAP Block; 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 and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present. In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared
Active Comparator: TAP block; Total abdominal plain block group will be given a TAP block	Drug: NSAID , NALUFIN , local anesthetic andTAP Block; 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 and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present. In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain	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	2 hours after the Cesarean Section till the pain relief

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Principal Investigator: ElSayed ElDesouky, Professor, Al-Azhar University, Faculty of medicine for boys

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): March 20, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: Mahmoud Raslan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No