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

Pain, Postoperative Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427059
• Other study ID #: ORL-CHIR-008
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: July 7, 2021

Study information

• Verified date: October 2021
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Lugano, Civico e Italiano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Fabio Garofalo

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants With Ropivacaine-Related Adverse Events		from surgery up to six weeks after surgery
Secondary	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
Secondary	lenght of hospital stay	number of days the participant is being hospitalized	during hospitalization,approximately 4 days
Secondary	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