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

Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Transversus Abdominis Plane (TAP) block; Procedure: Port-Site Infiltration (PSI)

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Ospedale Regionale di Lugano, Civico e Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A - laparoscopic assisted TAP block; 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; 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.
ACTIVE_COMPARATOR: Arm B - PSI; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 18 hours. 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 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	Number of participants with complications, defined as any alteration from the normal or uneventful postoperative course,	from surgery up to six weeks after surgery
lenght of hospital stay	number of days the participant is being hospitalized	during hospitalization,approximately 4 days
in hospital satisfaction	In hospital satisfaction (measured on the validated Leiden Perioperative Patient Satisfaction -LPPS - questionnaire for the perioperative patients' satisfaction. This questionnaire assess patient satisfaction with perioperative care. Patients are asked to score each question on a fivepoint scale (from 1 - corresponding to the worse outcome to 5 - the best outcome)	during hospitalization,approximately 4 days

Collaborators and Investigators

• Sponsor: Fabio Garofalo
• Investigators: Principal Investigator: Fabio Garofalo, MD, EOC Surgeery Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2020
• Primary Completion (ACTUAL): July 7, 2021
• Study Completion (ACTUAL): July 7, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Transversus Abdominis Plane (TAP) Block; Local Anesthetic Infiltrations
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ORL-CHIR-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No