- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154763
The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery (INOPAIN)
A Pilot Study to Assess the Feasibility of a Future Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Intra-Peritoneal Ropivacaine in Gastric Bypass Surgery: INOPAIN Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of of cardiovascular and pulmonary events. effective pain management may reduce their risk of serious postoperative complications, such as deep venous thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass.
Methods and Analysis: A randomized controlled trial will be conducted to compare intraperitoneal ropivacaine (Intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment as normal saline. The primary end point will be postoperative pain at 1, 2 and 4 hours postoperatively. Pain measurements will then occur every 4 hours for 24 h and every 8h until discharge. Secondary endpoints will include opioid use, peak expiratory flow, 6 min walk distance and quality of life. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed model approach. post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustments to the type 1 error. Results of the study will inform the feasibility of effectiveness of intraperitoneal ropivacaine.
Ethics and dissemination This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing Roux-en-Y gastric bypass surgery;
- Patients who able to tolerate general anesthetic and pneumoperitoneum;
- Patients who able to provide informed consent for the surgery;
- Patients over the age of 18 years;
Exclusion Criteria:
- Patient undergoing planned Sleeve Gastrectomy (inta-op conversion to Sleeve Gastrectomy after delivery of intraperitoneal ropivacaine will be included and analyzed using intention-to-treat approach)
- Patients with an allergy to local anesthetics
- Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
- Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/hr (millilitre per hour))
- Patients with hepatic dysfunction Child-Pugh Class B or C
- Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Intraperitoneal Normal Saline
Intraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm
|
Other Names:
|
Experimental: Intraperitoneal ropivacaine
The abdomen will be entered and trocars placed in the usual manner.
Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows.
Under direct visualization, 50mL (Milliliter) (of the 100mL) will be infused over the esophageal hiatus.
The remaining 50mL will be infused throughout the abdomen.
The infusion line will then be flushed with 30mL (Milliliter) of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing.
The remainder of the surgery will proceed as usual.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
0-1 h Postoperative Pain Level
Time Frame: 0-1 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
0-1 hours post operatively
|
1-2 h Postoperative Pain Level
Time Frame: 1-2 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
1-2 hours post operatively
|
2-4 Hours Post Operative Pain Level
Time Frame: 2-4 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
2-4 hours post operatively
|
4-8 Hours Post Operative Pain Level
Time Frame: 4-8 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
4-8 hours post operatively
|
8-12 Hours Post Operative Pain Level
Time Frame: 8-12 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
8-12 hours post operatively
|
12-16 Hours Post Operative Pain Level
Time Frame: 12-16 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
12-16 hours post operatively
|
16-20 Hours Post Operative Pain Level
Time Frame: 16-20 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
16-20 hours post operatively
|
20-24 Hours Post Operative Pain Level
Time Frame: 20-24 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
20-24 hours post operatively
|
24-32 Hours Post Operative Pain Level
Time Frame: 24-32 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
24-32 hours post operatively
|
32-40 Hours Post Operative Pain Level
Time Frame: 32-40 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
32-40 hours post operatively
|
40-48 Hours Post Operative Pain Level
Time Frame: 40-48 hours post operatively
|
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
|
40-48 hours post operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1h Peak Expiratory Flow (PEF) Score
Time Frame: 1 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
1 hours post operatively
|
2h Peak Expiratory Flow (PEF) Score
Time Frame: 2 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
2 hours post operatively
|
4h Peak Expiratory Flow (PEF) Score
Time Frame: 4 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
4 hours post operatively
|
8h Peak Expiratory Flow (PEF) Score
Time Frame: 8 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
8 hours post operatively
|
12h Peak Expiratory Flow (PEF) Score
Time Frame: 12 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
12 hours post operatively
|
16h Peak Expiratory Flow (PEF) Score
Time Frame: 16 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
16 hours post operatively
|
20h Peak Expiratory Flow (PEF) Score
Time Frame: 20 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
20 hours post operatively
|
24h Peak Expiratory Flow (PEF) Score
Time Frame: 24 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
24 hours post operatively
|
32h Peak Expiratory Flow (PEF) Score
Time Frame: 32 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
32 hours post operatively
|
40h Peak Expiratory Flow (PEF) Score
Time Frame: 40 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
40 hours post operatively
|
48h Peak Expiratory Flow (PEF) Score
Time Frame: 48 hours post operatively
|
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score.
Value recorded is based on an average of 3 readings at every time point.
|
48 hours post operatively
|
6 Minute Walking Distance Post Operative Day 1 (POD1)
Time Frame: Post operative day 1
|
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required.
walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur.
0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
|
Post operative day 1
|
6 Minute Walking Distance Post Operative Day 2 (POD2)
Time Frame: Post operative day 2
|
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required.
walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur.
0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
|
Post operative day 2
|
Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)
Time Frame: Post operative day 1
|
40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor) |
Post operative day 1
|
0-1 h Postoperative Tylenol Consumption
Time Frame: 0-1 hours post operatively
|
The amount in mg of Tylenol administered to the patient
|
0-1 hours post operatively
|
0-1 h Postoperative Ketorolac Consumption
Time Frame: 0-1 hours post operatively
|
The amount in mg of Ketorolac administered to patient
|
0-1 hours post operatively
|
0-1 h Postoperative Dilaudid Consumption
Time Frame: 0-1 hours post operatively
|
The amount in mg of Dilaudid administered to patient
|
0-1 hours post operatively
|
0-1 h Postoperative Tramadol Consumption
Time Frame: 0-1 h Postoperative Tramadol consumption
|
The amount in mg of Tramadol administered to patient
|
0-1 h Postoperative Tramadol consumption
|
0-1 h Postoperative Fentanyl Consumption
Time Frame: 0-1 hours post operatively
|
The amount in mcg of Fentanyl administered to patient
|
0-1 hours post operatively
|
1-2 h Postoperative Tylenol Consumption
Time Frame: 1-2 hours post operatively
|
The amount in mg of Tylenol administered to patient
|
1-2 hours post operatively
|
1-2 h Postoperative Ketorolac Consumption
Time Frame: 1-2 hours post operatively
|
The amount in mg of Ketorolac administered to patient
|
1-2 hours post operatively
|
1-2 h Postoperative Dilaudid Consumption
Time Frame: 1-2 hours post operatively
|
The amount in mg of Dilaudid administered to patient
|
1-2 hours post operatively
|
1-2 h Postoperative Tramadol Consumption
Time Frame: 1-2 hours post operatively
|
The amount in mg of Tramadol administered to patient
|
1-2 hours post operatively
|
1-2 h Postoperative Fentanyl Consumption
Time Frame: 1-2 hours post operatively
|
The amount in mcg of Fentanyl administered to patient
|
1-2 hours post operatively
|
2-4 h Postoperative Tylenol Consumption
Time Frame: 2-4 hours post operatively
|
The amount in mg of Tylenol administered to patient
|
2-4 hours post operatively
|
2-4 h Postoperative Ketorolac Consumption
Time Frame: 2-4 hours post operatively
|
The amount in mg of Ketorolac administered to patient
|
2-4 hours post operatively
|
2-4 h Postoperative Dilaudid Consumption
Time Frame: 2-4 hours post operatively
|
The amount in mg of Dilaudid administered to patient
|
2-4 hours post operatively
|
2-4 h Postoperative Tramadol Consumption
Time Frame: 2-4 hours post operatively
|
The amount in mg of Tramadol administered to patient
|
2-4 hours post operatively
|
2-4 h Postoperative Fentanyl Consumption
Time Frame: 2-4 hours post operatively
|
The amount in mcg of Fentanyl administered to patient
|
2-4 hours post operatively
|
4-12 h Postoperative Tylenol Consumption
Time Frame: 4-12 hours post operatively
|
The amount in mg of Tylenol administered to patient
|
4-12 hours post operatively
|
4-12 h Postoperative Ketorolac Consumption
Time Frame: 4-12 hours post operatively
|
The amount in mg of Ketorolac administered to patient
|
4-12 hours post operatively
|
4-12 h Postoperative Tramadol Consumption
Time Frame: 4-12 hours post operatively
|
The amount in mg of Tramadol administered to patient
|
4-12 hours post operatively
|
4-12 h Postoperative Dilaudid Consumption
Time Frame: 4-12 hours post operatively
|
The amount in mg of Dilaudid administered to patient
|
4-12 hours post operatively
|
12-24 h Postoperative Tylenol Consumption
Time Frame: 12-24 hours post operatively
|
The amount in mg of Tylenol administered to patient
|
12-24 hours post operatively
|
12-24 h Postoperative Ketorolac Consumption
Time Frame: 12-24 hours post operatively
|
The amount in mg of Ketorolac administered to patient
|
12-24 hours post operatively
|
12-24 h Postoperative Tramadol Consumption
Time Frame: 12-24 hours post operatively
|
The amount in mg of Tramadol administered to patient
|
12-24 hours post operatively
|
12-24 h Postoperative Dilaudid Consumption
Time Frame: 12-24 hours post operatively
|
The amount in mg of Dilaudid administered to patient
|
12-24 hours post operatively
|
24-48 h Postoperative Tylenol Consumption
Time Frame: 24-48 hours post operatively
|
The amount in mg of Tylenol administered to patient
|
24-48 hours post operatively
|
24-48 h Postoperative Ketorolac Consumption
Time Frame: 24-48 hours post operatively
|
The amount in mg of Ketorolac administered to patient
|
24-48 hours post operatively
|
24-48 h Postoperative Tramadol Consumption
Time Frame: 24-48 hours post operatively
|
The amount in mg of Tramadol administered to patient
|
24-48 hours post operatively
|
24-48 h Postoperative Dilaudid Consumption
Time Frame: 24-48 hours post operatively
|
The amount in mg of Dilaudid administered to patient
|
24-48 hours post operatively
|
Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)
Time Frame: Post operative day 7-10
|
40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor) |
Post operative day 7-10
|
6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)
Time Frame: Post operative day 7-10 (Follow-up Clinic)
|
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required.
walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur.
0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
|
Post operative day 7-10 (Follow-up Clinic)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joseph Mamazza, MD, The Ottawa Hospital
Publications and helpful links
General Publications
- Jarrar A, Eipe N, Wu R, Neville A, Yelle JD, Mamazza J. Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study. Can J Surg. 2021 Nov 10;64(6):E603-E608. doi: 10.1503/cjs.017719. Print 2021 Nov-Dec.
- Wu R, Haggar F, Porte N, Eipe N, Raiche I, Neville A, Yelle JD, Ramsay T, Mamazza J. Assessing the feasibility of a randomised, double-blinded, placebo-controlled trial to investigate the role of intraperitoneal ropivacaine in gastric bypass surgery: a protocol. BMJ Open. 2014 Aug 11;4(8):e005823. doi: 10.1136/bmjopen-2014-005823.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 717602410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Bariatric Surgery Candidate
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruitingGERD | Bariatric Surgery Candidate | Revisional Bariatric SurgeryVenezuela
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruiting
-
University of Illinois at Urbana-ChampaignCarle Foundation HospitalRecruitingBariatric Surgery Candidate | Bariatric Surgical ProcedureUnited States
-
L. van HogezandRijnstate HospitalNot yet recruitingBariatric Surgery Candidate
-
University Hospital, Clermont-FerrandRecruitingBariatric Surgery CandidateFrance
-
Tanta UniversityNot yet recruitingBariatric Surgery Candidate
-
Federal University of UberlandiaCompletedBariatric Surgery CandidateBrazil
-
Intuitive SurgicalActive, not recruiting
-
ElsanCemka-EvalWithdrawnBariatric Surgery CandidateFrance
-
Intuitive SurgicalCompletedBariatric Surgery CandidateUnited States
Clinical Trials on Ropivacaine
-
Ziekenhuis Oost-LimburgNot yet recruitingAnesthesia | Hallux Valgus
-
University Health Network, TorontoUnknownPIB Versus CI Through a Popliteal Sciatic Nerve Catheter for Analgesia Following Major Ankle SurgeryPain, PostoperativeCanada
-
Northwestern UniversityCompletedPostoperative PainUnited States
-
Hospices Civils de LyonCompleted
-
Pusan National University HospitalCompletedHemodynamics | Epidural Anesthesia | Ropivacaine ConcentrationKorea, Republic of
-
Northwestern UniversityCompletedObesity | Postoperative Pain | PregnancyUnited States
-
Universiteit AntwerpenCompleted
-
San Gerardo HospitalIRCCS Policlinico S. Matteo; University of Milano Bicocca; Azienda L'ULSS 15... and other collaboratorsCompletedLaparoscopic CholecystectomyItaly
-
China Medical University, ChinaWithdrawn
-
China Medical University, ChinaCompleted