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

Egymedicalpedia

Status and phase: Completed; Phase 1

Conditions: Cesarean Section Pain; Post Operative Pain

Treatments: Drug: NSAID , NALUFIN , local anesthetic andTAP Block

Study type: Interventional

Funder types: Industry

Identifiers

NCT05276206

Mahmoud Raslan

Details and patient eligibility

About

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

Full 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

Enrollment: 400 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups

NSAID

Active Comparator group

Description:

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

Treatment:

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

Nalufin

Active Comparator group

Description:

group will be given IV nalufin

Treatment:

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

local anesthetic group

Active Comparator group

Description:

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

Treatment:

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

TAP block

Active Comparator group

Description:

Total abdominal plain block group will be given a TAP block

Treatment:

Drug: NSAID , NALUFIN , local anesthetic andTAP Block