A Study to Compare Two Techniques for Pain Control After Bariatric Surgery

Fabio Garofalo

Status: Completed

Conditions: Bariatric Surgery Candidate; Pain, Postoperative

Treatments: Procedure: Port-Site Infiltration (PSI); Procedure: Transversus Abdominis Plane (TAP) block

Study type: Interventional

Funder types: Other

Identifiers

NCT04427059

ORL-CHIR-008

Details and patient eligibility

About

The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective bariatric surgery
• age ≥ 18 years
• signed informed consent

Exclusion criteria

• Pregnant or lactating women,
• known allergy to local anesthetics
• Chronic pain syndrome.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 2 patient groups

Arm A - laparoscopic assisted TAP block

Experimental group

Description:

Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (TPA).

Treatment:

Procedure: Transversus Abdominis Plane (TAP) block

Arm B - PSI

Active Comparator group

Description:

Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (PSI).

Treatment:

Procedure: Port-Site Infiltration (PSI)