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

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Pain, Postoperative
• Interventions: Procedure: Transversus Abdominis Plane (TAP) block; Procedure: Port-Site Infiltration (PSI)

• Registration Number: NCT04427059
• Lead Sponsor: Fabio Garofalo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Study Start: 2020-06-15
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A - laparoscopic assisted TAP block	Transversus Abdominis Plane (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).
Arm B - PSI	Port-Site Infiltration (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).

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	at 24 hours post surgery	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.

Secondary Outcome Measures

Name	Time	Method
in hospital satisfaction	during hospitalization,approximately 4 days	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)
postoperative pain	at 3, 6, 12, 18 hours from surgery	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.
Number of participants with complications	from surgery up to six weeks after surgery	Number of participants with complications, defined as any alteration from the normal or uneventful postoperative course,
lenght of hospital stay	during hospitalization,approximately 4 days	number of days the participant is being hospitalized
Number of Participants With Ropivacaine-Related Adverse Events	from surgery up to six weeks after surgery

Trial Locations

Locations (1)

Ospedale Regionale di Lugano, Civico e Italiano; 🇨🇭 Lugano, Switzerland