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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05831501
Other study ID # IERB/02/2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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