The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery

Bariatric Surgery Candidate Clinical Trial

— INOPAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154763
• Other study ID #: 717602410
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Drug:
• Ropivacaine

• Normal Saline

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 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
Secondary	0-1 h Postoperative Tylenol Consumption	The amount in mg of Tylenol administered to the patient	0-1 hours post operatively
Secondary	0-1 h Postoperative Ketorolac Consumption	The amount in mg of Ketorolac administered to patient	0-1 hours post operatively
Secondary	0-1 h Postoperative Dilaudid Consumption	The amount in mg of Dilaudid administered to patient	0-1 hours post operatively
Secondary	0-1 h Postoperative Tramadol Consumption	The amount in mg of Tramadol administered to patient	0-1 h Postoperative Tramadol consumption
Secondary	0-1 h Postoperative Fentanyl Consumption	The amount in mcg of Fentanyl administered to patient	0-1 hours post operatively
Secondary	1-2 h Postoperative Tylenol Consumption	The amount in mg of Tylenol administered to patient	1-2 hours post operatively
Secondary	1-2 h Postoperative Ketorolac Consumption	The amount in mg of Ketorolac administered to patient	1-2 hours post operatively
Secondary	1-2 h Postoperative Dilaudid Consumption	The amount in mg of Dilaudid administered to patient	1-2 hours post operatively
Secondary	1-2 h Postoperative Tramadol Consumption	The amount in mg of Tramadol administered to patient	1-2 hours post operatively
Secondary	1-2 h Postoperative Fentanyl Consumption	The amount in mcg of Fentanyl administered to patient	1-2 hours post operatively
Secondary	2-4 h Postoperative Tylenol Consumption	The amount in mg of Tylenol administered to patient	2-4 hours post operatively
Secondary	2-4 h Postoperative Ketorolac Consumption	The amount in mg of Ketorolac administered to patient	2-4 hours post operatively
Secondary	2-4 h Postoperative Dilaudid Consumption	The amount in mg of Dilaudid administered to patient	2-4 hours post operatively
Secondary	2-4 h Postoperative Tramadol Consumption	The amount in mg of Tramadol administered to patient	2-4 hours post operatively
Secondary	2-4 h Postoperative Fentanyl Consumption	The amount in mcg of Fentanyl administered to patient	2-4 hours post operatively
Secondary	4-12 h Postoperative Tylenol Consumption	The amount in mg of Tylenol administered to patient	4-12 hours post operatively
Secondary	4-12 h Postoperative Ketorolac Consumption	The amount in mg of Ketorolac administered to patient	4-12 hours post operatively
Secondary	4-12 h Postoperative Tramadol Consumption	The amount in mg of Tramadol administered to patient	4-12 hours post operatively
Secondary	4-12 h Postoperative Dilaudid Consumption	The amount in mg of Dilaudid administered to patient	4-12 hours post operatively
Secondary	12-24 h Postoperative Tylenol Consumption	The amount in mg of Tylenol administered to patient	12-24 hours post operatively
Secondary	12-24 h Postoperative Ketorolac Consumption	The amount in mg of Ketorolac administered to patient	12-24 hours post operatively
Secondary	12-24 h Postoperative Tramadol Consumption	The amount in mg of Tramadol administered to patient	12-24 hours post operatively
Secondary	12-24 h Postoperative Dilaudid Consumption	The amount in mg of Dilaudid administered to patient	12-24 hours post operatively
Secondary	24-48 h Postoperative Tylenol Consumption	The amount in mg of Tylenol administered to patient	24-48 hours post operatively
Secondary	24-48 h Postoperative Ketorolac Consumption	The amount in mg of Ketorolac administered to patient	24-48 hours post operatively
Secondary	24-48 h Postoperative Tramadol Consumption	The amount in mg of Tramadol administered to patient	24-48 hours post operatively
Secondary	24-48 h Postoperative Dilaudid Consumption	The amount in mg of Dilaudid administered to patient	24-48 hours post operatively
Secondary	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 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
Secondary	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)