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Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

NCT ID: NCT02641288

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ropivacaine irrigation

Using a standard irrigation device, 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.

Group Type EXPERIMENTAL

Ropivacaine irrigation

Intervention Type DRUG

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.

Normal saline irrigation

Using a standard irrigation device, 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.

Group Type PLACEBO_COMPARATOR

Normal saline irrigation

Intervention Type DRUG

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.

Interventions

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Ropivacaine 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.

Intervention Type DRUG

Normal 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.

Intervention Type DRUG

Other Intervention Names

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Intraperitoneal Ropivacaine irrigation Intraperitoneal Normal saline irrigation

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Gonzalez, MD

Role: STUDY_DIRECTOR

Hospital General Elche

References

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Ruiz-Tovar J, Gonzalez J, Garcia A, Cruz C, Rivas S, Jimenez M, Ferrigni C, Duran M. Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery: a Prospective Randomized Clinical Trial. Obes Surg. 2016 Nov;26(11):2616-2621. doi: 10.1007/s11695-016-2142-z.

Reference Type DERIVED
PMID: 27007272 (View on PubMed)

Other Identifiers

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HURJC15-77

Identifier Type: -

Identifier Source: org_study_id