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

NCT ID: NCT05276206

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-04-01

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

Conditions

Post Operative Pain; Cesarean Section Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NSAID

The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need

Group Type: ACTIVE_COMPARATOR

NSAID , NALUFIN , local anesthetic andTAP Block

Intervention Type: DRUG

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

Nalufin

group will be given IV nalufin

Group Type: ACTIVE_COMPARATOR

NSAID , NALUFIN , local anesthetic andTAP Block

Intervention Type: DRUG

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

local anesthetic group

the local anesthetic group will be given a S.C injection of local anesthetic in the wound

Group Type: ACTIVE_COMPARATOR

NSAID , NALUFIN , local anesthetic andTAP Block

Intervention Type: DRUG

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

TAP block

Total abdominal plain block group will be given a TAP block

Group Type: ACTIVE_COMPARATOR

NSAID , NALUFIN , local anesthetic andTAP Block

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ElSayed ElDesouky, Professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University, Faculty of medicine for boys

Locations

Al-Azhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Mahmoud Raslan

Identifier Type: -

Identifier Source: org_study_id