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

NCT04427059 | Completed

• 1 other identifier: ORL-CHIR-008
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Bariatric Surgery Candidate

Keywords

Transversus Abdominis Plane (TAP) Block; Local Anesthetic Infiltrations

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.

  at 24 hours post surgery

Secondary Outcomes (5)

• postoperative pain

  at 3, 6, 12, 18 hours from surgery

• Number of Participants With Ropivacaine-Related Adverse Events

  from surgery up to six weeks after surgery

• Number of participants with complications

  from surgery up to six weeks after surgery

• lenght of hospital stay

  during hospitalization,approximately 4 days

• in hospital satisfaction

  during hospitalization,approximately 4 days

Study Arms (2)

Arm A - laparoscopic assisted TAP block

EXPERIMENTAL

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).

Procedure: Transversus Abdominis Plane (TAP) block

Arm B - PSI

ACTIVE COMPARATOR

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).

Procedure: Port-Site Infiltration (PSI)

Interventions

Transversus Abdominis Plane (TAP) block PROCEDURE

The laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum. A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle. The procedure is then repeated identically on the contralateral side.

Arm A - laparoscopic assisted TAP block

Port-Site Infiltration (PSI) PROCEDURE

The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered.

Arm B - PSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fabio Garofalo: lead

Study Sites (1)

Ospedale Regionale di Lugano, Civico e Italiano

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Fabio Garofalo, MD

  EOC Surgeery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 11, 2020
• Study Start: June 15, 2020
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)