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
About this trial
This is an interventional prevention trial for TAP and RS Block
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
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
NCT ID
NCT03536741
First Posted
March 9, 2018
Last Updated
May 23, 2018
Sponsor
Campus Bio-Medico University
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
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Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures
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