Pain, Postoperative Pain, Acute Pain, Analgesia, Bariatric Surgery Candidate, Anesthesia
Conditions
Brief summary
This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic gastric bypass. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).
Interventions
The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Ropivacaine 0.5% on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
PROCEDUREPort site infiltration
Prior the surgical incision, an infiltration of the laparoscopic access using a total of 10 ml Ropivacaine 0.5% was performed by surgeon
The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
Sponsors
Fondazione Policlinico Universitario Campus Bio-Medico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective Laparoscopic Gastric Bypass * Body Mass Index (BMI) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc) * BMI \> 40 kg/m², even in the absence of comorbidities * ASA physical status score \< 4
Exclusion criteria
* ASA physical status score ≥ 4 * Patient's refusal or inability to sign the informed consent * Allergies to any drug provided by the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 24 hours | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ketorolac Consumption | 24 hours | Total of intravenous toradol (expressed in milligrams) administered administered during the first 24 hours after surgery |
| Nausea and/or Vomiting | 48 hours | Incidence of nausea and/or vomiting |
| Length of Hospital Stay | 72 hours | Time between surgery and dismission from the hospital |
| Morphine Consumption | 24 hours | Total of intravenous morphine (expressed in milligrams) administered administered during the first 24 hours after surgery |
| Time to first flatus | 72 hours | Time between surgery and patient having flatus |
| Surgical Complications | 7 days | Incidence of complications related to surgery |
| Timt to walking | 72 hours | Time between surgery and patient starting to walk |
Countries
Italy
Outcome results
None listed