Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Post Operative Pain Clinical Trial

Official title:

Postoperative Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Caesarean Section, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831501
• Other study ID #: IERB/02/2023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Armed Forces Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

Description:

The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. The study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. All patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of Group B on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Elective Caesarean section

• ASA 1-3

• 20yrs to 45yrs

Exclusion Criteria:

• Emergency Surgery

• known allergy to local anaesthetic

• severe pre-eclampsia

• placenta accreta

• ASA 4

• Coagulopathy

• Hemodynamically unstable

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Trans abdominis plane block
Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.

Locations

Country	Name	City	State
Pakistan	Combined Military Hospital	Sargodha	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	within 24hours after surgery	24 hours post cesarean section
Secondary	Pain intensity Score	Pain intensity at 6 hours,12 hours and 24 hours after surgery	from end of secarean section till 24 post operative hours
Secondary	Vomiting	frequency of vomiting within 24hours after surgery	Within 24hours after surgery
Secondary	Duration of First Rescue Analgesia	time after surgery when first dose of opioid required	Within 24hours after surgery