The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
This is a pilot study in a randomized, controlled, double-blinded format and will evaluate the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass surgery. The drug will be administered into the abdomen during a bariatric bypass surgery. After surgery, patients who received Ropivacaine will be compared to those without Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to walk, and quality of life during recovery.

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.

Official Title
-----------------
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

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Intraperitoneal Normal Saline<br>Intraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm | Drug: Normal Saline<br> <br> * Other names: 7647-14-5;|
| Experimental: Intraperitoneal ropivacaine<br>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. | Drug: Ropivacaine<br> <br> * Other names: 84057-95-4;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0-1 h Postoperative Pain Level | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor) | Post operative day 1 | 
| 0-1 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to the patient | 0-1 hours post operatively | 
| 0-1 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 0-1 hours post operatively | 
| 0-1 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 0-1 hours post operatively | 
| 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 | The amount in mcg of Fentanyl administered to patient | 0-1 hours post operatively | 
| 1-2 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 1-2 hours post operatively | 
| 1-2 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 1-2 hours post operatively | 
| 1-2 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 1-2 hours post operatively | 
| 1-2 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 1-2 hours post operatively | 
| 1-2 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | 1-2 hours post operatively | 
| 2-4 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 2-4 hours post operatively | 
| 2-4 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 2-4 hours post operatively | 
| 2-4 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 2-4 hours post operatively | 
| 2-4 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 2-4 hours post operatively | 
| 2-4 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | 2-4 hours post operatively | 
| 4-12 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 4-12 hours post operatively | 
| 4-12 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 4-12 hours post operatively | 
| 4-12 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 4-12 hours post operatively | 
| 4-12 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 4-12 hours post operatively | 
| 12-24 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 12-24 hours post operatively | 
| 12-24 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 12-24 hours post operatively | 
| 12-24 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 12-24 hours post operatively | 
| 12-24 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 12-24 hours post operatively | 
| 24-48 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 24-48 hours post operatively | 
| 24-48 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 24-48 hours post operatively | 
| 24-48 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 24-48 hours post operatively | 
| 24-48 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 24-48 hours post operatively | 
| Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40) | 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 answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor) | Post operative day 7-10 | 
| 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatrics, Ropivacaine, Bariatric surgery, Local anesthetic, Intraperitoneal