NCT02641288

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

December 18, 2015

Last Update Submit

December 22, 2015

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain

    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).

    24 hours postoperatively

Study Arms (2)

Ropivacaine irrigation

EXPERIMENTAL

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.

Drug: Ropivacaine irrigation

Normal saline irrigation

PLACEBO COMPARATOR

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.

Drug: Normal saline irrigation

Interventions

Ropivacaine irrigationDRUG

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.

Also known as: Intraperitoneal Ropivacaine irrigation
Ropivacaine irrigation
Normal saline irrigationDRUG

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.

Also known as: Intraperitoneal Normal saline irrigation
Normal saline irrigation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27007272DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan Gonzalez, MD

    Hospital General Elche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 18, 2015

First Posted

December 29, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12