Clinical trial NCT05276206: Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
Official title: Comparative Study Between Transversus Abdominus Plain Block, Local Subcutaneous Injection in the Wound, and Intravenous Nalbuphine in Decreasing Postoperative Pain in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post Operative Pain
Cesarean Section Pain
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Post Operative Pain
timeFrame: 2 hours after the Cesarean Section till the pain relief
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
affiliation: Al-Azhar University, Faculty of medicine for boys
name: ElSayed ElDesouky, Professor
role: PRINCIPAL_INVESTIGATOR
References: