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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
The Ottawa Hospital
Ottawa, Ontario, Canada
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12-16 hours post operatively
16-20 Hours Post Operative Pain Level
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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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 40-48 hours post operatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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 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)
Time frame: Post operative day 1
0-1 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to the patient
Time frame: 0-1 hours post operatively
0-1 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 0-1 hours post operatively
0-1 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 0-1 hours post operatively
0-1 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 0-1 h Postoperative Tramadol consumption
0-1 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Time frame: 0-1 hours post operatively
1-2 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 1-2 hours post operatively
1-2 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 1-2 hours post operatively
1-2 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 1-2 hours post operatively
1-2 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 1-2 hours post operatively
1-2 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Time frame: 1-2 hours post operatively
2-4 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 2-4 hours post operatively
2-4 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 2-4 hours post operatively
2-4 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 2-4 hours post operatively
2-4 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 2-4 hours post operatively
2-4 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Time frame: 2-4 hours post operatively
4-12 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 4-12 hours post operatively
4-12 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 4-12 hours post operatively
4-12 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 4-12 hours post operatively
4-12 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 4-12 hours post operatively
12-24 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 12-24 hours post operatively
12-24 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 12-24 hours post operatively
12-24 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 12-24 hours post operatively
12-24 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 12-24 hours post operatively
24-48 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 24-48 hours post operatively
24-48 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 24-48 hours post operatively
24-48 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 24-48 hours post operatively
24-48 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 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 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)
Time frame: 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)
Time frame: Post operative day 7-10 (Follow-up Clinic)