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

NCT ID: NCT07051499

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-21

Study Completion Date

2026-01-21

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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tap block group

\- 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).

No interventions assigned to this group

intravenous analgesia

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.

TAP Block Group

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years, scheduled for elective gynecological surgery

Exclusion Criteria

* age \<18, emergency surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Michela Rauseo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico di Foggia

Foggia, Apulia, Italy

Site Status

Countries

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Italy

Other Identifiers

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TAP BLOCK GYNECOLOGIC SURGERY

Identifier Type: -

Identifier Source: org_study_id

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