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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536741
Recruitment Status : Unknown
Verified May 2018 by Corrado Terranova, Campus Bio-Medico University.
Recruitment status was:  Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Corrado Terranova, 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.

Condition or disease Intervention/treatment Phase
TAP and RS Block Procedure: TAP block and RS block + General Intravenous Anesthestic Drug: General Intravenous Anesthetic Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : July 12, 2018
Estimated Study Completion Date : July 12, 2018

Arm Intervention/treatment
Experimental: ALR Procedure: TAP block and RS block + General Intravenous Anesthestic
transversus abdominis plane block and rectus sheath block

Active Comparator: EV Drug: General Intravenous Anesthetic
General Intravenous Anesthetic




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • Previous opioids consumption for chronic pain
  • Neurological or cognitive disorders
  • Conversion from laparoscopic to open surgery
  • Onset of intraoperative complications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536741


Locations
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Italy
Campus Bio-medico Recruiting
Roma, RM, Italy, 00128
Contact: Corrado Terranova    06225411203    c.terranova@unicampus.it   
Sponsors and Collaborators
Campus Bio-Medico University
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Responsible Party: Corrado Terranova, Principal Investigator, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT03536741    
Other Study ID Numbers: GIN-TAP 2017
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Anesthetics
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General