Effectiveness of TAP Block Versus Intravenous Analgesia in Postoperative Pain Management Following Gynecologic Laparoscopic Surgery

Active, not recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: TAP Block Group

• Registration Number: NCT07051499
• Lead Sponsor: University of Foggia

Brief Summary

Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. However, data comparing TAP block directly with standard intravenous analgesia in this surgical context are limited.

Detailed Description

This prospective, randomized controlled trial included patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery). Patients were randomized into two groups:

* TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).

* Intravenous Analgesia Group: Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.

Primary outcome: Postoperative pain intensity (NRS) at 1, 6, and 24 hours. Secondary outcomes included additional analgesic use, side effects, and patient satisfaction.

Study Timeline

• Study Start: 2025-01-21
• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-01-21
• Study Completion: 2026-01-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• age > 18 years, scheduled for elective gynecological surgery

Exclusion Criteria

• age <18, emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intravenous analgesia	TAP Block Group	Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity (Numeric Rating Scale)	1, 6, 24 hours postoperatively.	Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at 1, 6, and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Total Analgesic Consuption.	0-24 hours postoperatively.	Total dose of tramadol (in Milligrams) administered in the first 24 hours after surgery will be recorded and compared between groups.
Incidence of Side Effects.	0-24 hours postoperatively	Occurrence of side effects such nausea, vomiting and sedation will be recorded and expressed as a percentage of patients (%) affected in each group.
Patient Satisfaction With Analgesia	24 hours postoperatively	Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale (1= very dissatisfied; 5= very satisfied) at 24 hours after surgery.

Trial Locations

Locations (1)

Policlinico di Foggia; 🇮🇹 Foggia, Puglia, Italy