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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276206
• Other study ID #: Mahmoud Raslan
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2022
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 1, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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