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Clinical Trials/NCT03536741
NCT03536741
Unknown
Phase 2

The Role of Transversus Abdominis Plane Block and Rectus Sheath Block in Reduction of Postoperative Pain for Gynecological Benign Surgical Laparoscopic Procedures: a Randomized Controlled Trial

Campus Bio-Medico University1 site in 1 country70 target enrollmentOctober 12, 2017

Overview

Phase
Phase 2
Intervention
TAP block and RS block + General Intravenous Anesthestic
Conditions
TAP and RS Block
Sponsor
Campus Bio-Medico University
Enrollment
70
Locations
1
Primary Endpoint
analgesic consumption in the first 72 hours after gynecological surgical procedures
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2017
End Date
July 12, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Campus Bio-Medico University
Responsible Party
Principal Investigator
Principal Investigator

Corrado Terranova

Principal Investigator

Campus Bio-Medico University

Eligibility Criteria

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

Arms & Interventions

ALR

Intervention: TAP block and RS block + General Intravenous Anesthestic

EV

Intervention: General Intravenous Anesthetic

Outcomes

Primary Outcomes

analgesic consumption in the first 72 hours after gynecological surgical procedures

Time Frame: 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

Time Frame: postoperative pain in the first 72 hours after gynecological surgical procedures

postoperative pain in the first 72 hours after gynecological surgical procedures

Study Sites (1)

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