Bariatric Surgery Candidate, Pain, Postoperative
Conditions
Keywords
Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations
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.
Interventions
PROCEDURETransversus 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.
PROCEDUREPort-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.
Sponsors
Fabio Garofalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 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 |
| 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) |
Countries
Switzerland
Outcome results
None listed