Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02641288

Enrollment

110

Registered

2015-12-29

Start date

2015-01-31

Completion date

2015-12-31

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).

Detailed description

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).

Interventions

DRUGRopivacaine irrigation

Using a standard irrigation device (no specific device is being used), 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.

DRUGNormal saline irrigation

Using a standard irrigation device (no specific device is being used), 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Body mass index (BMI) \>40 Kg/m2 * BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity.

Exclusion criteria

* patients undergoing other bariatric techniques or revisional surgery * allergy to local anesthetics * severe underlying cardiovascular diseases * chronic renal failure * hepatic dysfunction * previous foregut surgery * patients with any contraindication for bariatric surgery.

Design outcomes

Primary

Measure	Time frame	Description
Pain	24 hours postoperatively	Postoperative pain will be evaluated by a blinded nurse 24 hours after surgery. Pain will be quantified using a visual analogic scale (VAS), ranging from 0(absence of pain) to 10 (unbearable pain).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026