Postoperative Pain Relief After Major Abdominal Gynecological Surgery

Postoperative Pain Clinical Trial

Official title:

Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845385
• Other study ID #: MAS
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Cukurova University
• Contact: hakki unlugenc, professor
• Phone: 05336417891
• Email: hunlugenc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.

Description:

Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• ASA I-II,
• between the age of 18-69,
• undergoing major gynecological abdominal surgery under general anesthesia

Exclusion Criteria:

• lack of patient consent
• ASA > III
• sensitivity or contraindication to study drugs
• conditions in which epidural anesthesia is contraindicated
• emergency and urgent surgery
• inability to comprehend pain scale
• any contraindication to the use of patient controlled analgesia (PCA) device.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• lumbar epidural analgesia with bupivacaine
postoperative analgesic method
• transversus abdominis plane block with bupivacaine
postoperative analgesic method
• wound infiltration with bupivacaine
postoperative analgesic method

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	At the end of the surgery, the patients were allowed to use the patient controlled analgesia device (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc. St. Paul, MN) was prepared with 40 mg morphine HCl in 100 ml saline. The PCA doses of morphine consisted of a bolus dose of 0.02 mg/kg every 15 minutes without a background infusion. Morphine consumption (mg) was evaluated and recorded postoperative 48 hours.	change from baseline morphine comsumption at 48 hours
Secondary	pain scores	postoperative pain scores of the patients were recorded using visual analog scale (VAS; 0=no pain, 10=worst pain)	change from baseline pain scores at 48 hours
Secondary	patient satisfaction score	patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)	postoperative 24 and 48 hours
Secondary	time to first rescue analgesic	If the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.	postoperative 48 hours
Secondary	side effects	all patients were visited after surgery in the ward and side effects were evaluated and recorded	postoperative 48 hours