- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641288
Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery
December 22, 2015 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Placebo Comparator: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 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).
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Juan Gonzalez, MD, Hospital General Elche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 18, 2015
First Submitted That Met QC Criteria
December 22, 2015
First Posted (Estimate)
December 29, 2015
Study Record Updates
Last Update Posted (Estimate)
December 29, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HURJC15-77
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Ropivacaine irrigation
-
Cairo UniversityUnknown
-
University of California, San FranciscoCompleted
-
Children's Hospitals and Clinics of MinnesotaWithdrawnFacial and Scalp LacerationsUnited States
-
Guy's and St Thomas' NHS Foundation TrustNot yet recruitingConstipation | Constipation - Functional | Defecation Disorder | Constipation by Outlet Obstruction
-
University of AlbertaCompletedChronic Rhinosinusitis
-
Hospital Universitario Virgen de la ArrixacaUnknownAcute Disease | Appendicitis | Abdominal Abscess | Cecal Diseases | InfectionSpain
-
Children's Mercy Hospital Kansas CityCompleted
-
University of AarhusKarolinska University Hospital; Coloplast A/S; Central Jutland Regional Hospital and other collaboratorsCompletedConstipation | Fecal Incontinence | Spinal Cord InjuryDenmark
-
Istanbul Medipol University HospitalCompletedPeriapical Periodontitis | Root Canal InfectionTurkey
-
Trakya UniversityCompletedImpacted Third Molar ToothTurkey