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

TAP and RS Block Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536741
• Other study ID #: GIN-TAP 2017
• Status: Recruiting
• Phase: Phase 2
• Start date: October 12, 2017
• Est. completion date: July 12, 2018

Study information

• Verified date: May 2018
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• TAP and RS Block

Intervention

Procedure:
• TAP block and RS block + General Intravenous Anesthestic
transversus abdominis plane block and rectus sheath block

Drug:
• General Intravenous Anesthetic
General Intravenous Anesthetic

Locations

Country	Name	City	State
Italy	Campus Bio-medico	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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