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NCT Number: NCT07051499

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

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.

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Policlinico di Foggia

Foggia, Apulia, 71122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years, scheduled for elective gynecological surgery

Exclusion criteria

  • age <18, emergency surgery

Treatment and study plan

TAP Block Group

Drug

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

Primary outcomes

  1. Postoperative pain intensity (Numeric Rating Scale)

    Time frame: 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 outcomes

  1. Total Analgesic Consuption.

    Time frame: 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.

  2. Incidence of Side Effects.

    Time frame: 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.

  3. Patient Satisfaction With Analgesia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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