Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures

Phase 2

• Conditions: TAP and RS Block
• Interventions: Drug: General Intravenous Anesthetic; Procedure: TAP block and RS block + General Intravenous Anesthestic

• Registration Number: NCT03536741
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-12
• Study First Submitted: 2018-03-09
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-23
• Last Update Submitted: 2018-05-23
• Study First Posted: 2018-05-25
• Last Update Posted: 2018-05-25
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• patients undergoing benign laparoscopic gynecological surgery
• age between 18 and 75 years
• BMI >18 e <35
• ECOG Performance Status 0-1

Exclusion Criteria

• age < 18 or > 75 years
• BMI <18 or > 35
• ECOG Performance Status >1
• Allergy to local anesthetics
• Allergy to NSAIDs
• Chronic kidney failure > II class
• Systemic neoplastic disease actual or previous
• Actual pregnancy
• Active or recent pelvic inflammation
• Persistent coagulopathy
• Previous opioids consumption for chronic pain
• Neurological or cognitive disorders
• Conversion from laparoscopic to open surgery
• Onset of intraoperative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EV	General Intravenous Anesthetic	-
ALR	TAP block and RS block + General Intravenous Anesthestic	-

Primary Outcome Measures

Name	Time	Method
analgesic consumption in the first 72 hours after gynecological surgical procedures	analgesic consumption in the first 72 hours after gynecological surgical procedures	analgesic consumption in the first 72 hours after gynecological surgical procedures
postoperative pain in the first 72 hours after gynecological surgical procedures	postoperative pain in the first 72 hours after gynecological surgical procedures	postoperative pain in the first 72 hours after gynecological surgical procedures

Trial Locations

Locations (1)

Campus Bio-medico; 🇮🇹 Roma, RM, Italy