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

Primary Purpose

TAP and RS Block

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
TAP block and RS block + General Intravenous Anesthestic
General Intravenous Anesthetic
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for TAP and RS Block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Campus Bio-medicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALR

EV

Arm Description

Outcomes

Primary Outcome Measures

postoperative pain in the first 72 hours after gynecological surgical procedures
postoperative pain 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

Secondary Outcome Measures

Full Information

First Posted
March 9, 2018
Last Updated
May 23, 2018
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT03536741
Brief Title
Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
July 12, 2018 (Anticipated)
Study Completion Date
July 12, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TAP and RS Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALR
Arm Type
Experimental
Arm Title
EV
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TAP block and RS block + General Intravenous Anesthestic
Intervention Description
transversus abdominis plane block and rectus sheath block
Intervention Type
Drug
Intervention Name(s)
General Intravenous Anesthetic
Intervention Description
General Intravenous Anesthetic
Primary Outcome Measure Information:
Title
postoperative pain in the first 72 hours after gynecological surgical procedures
Description
postoperative pain in the first 72 hours after gynecological surgical procedures
Time Frame
postoperative pain in the first 72 hours after gynecological surgical procedures
Title
analgesic consumption in the first 72 hours after gynecological surgical procedures
Description
analgesic consumption in the first 72 hours after gynecological surgical procedures
Time Frame
analgesic consumption in the first 72 hours after gynecological surgical procedures

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Previous opioids consumption for chronic pain Neurological or cognitive disorders Conversion from laparoscopic to open surgery Onset of intraoperative complications
Facility Information:
Facility Name
Campus Bio-medico
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrado Terranova
Phone
06225411203
Email
c.terranova@unicampus.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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