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

Campus Bio-Medico University of Rome

Status and phase: Unknown; Phase 2

Conditions: TAP and RS Block

Treatments: Procedure: TAP block and RS block + General Intravenous Anesthestic; Drug: General Intravenous Anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT03536741

GIN-TAP 2017

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

ALR

Experimental group

Treatment:

Procedure: TAP block and RS block + General Intravenous Anesthestic

EV

Active Comparator group

Treatment:

Drug: General Intravenous Anesthetic