Bariatric Surgery CandidatePhase 3INOPAINNCT02154763

The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery

A Phase 3 study testing Ropivacaine and Normal Saline in people with Bariatric Surgery Candidate, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Bariatric Surgery Candidate
What is being tested?: Ropivacaine and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteCanada
Study dates: Jul 2014to Jul 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Bariatric Surgery Candidate
Being tested: Ropivacaine, Normal Saline
Keywords: Bariatric surgery, Bariatrics, Local anesthetic, Ropivacaine, Intraperitoneal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RopivacaineDrug
Also called NAROPIN®, 84057-95-4
Normal SalineDrug
Also called Sodium Chloride, 7647-14-5

Study groups in NCT02154763
Study group	Role	What they receive
Intraperitoneal Normal Saline	Placebo comparator	Intraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm Receives: Drug: Normal Saline
Intraperitoneal ropivacaine	Experimental	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. Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 40-48 hours post operatively

Secondary outcomes (43)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post operative day 1
0-1 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to the patient
Measured: 0-1 hours post operatively
0-1 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Measured: 0-1 hours post operatively
0-1 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Measured: 0-1 hours post operatively
0-1 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Measured: 0-1 h Postoperative Tramadol consumption
0-1 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Measured: 0-1 hours post operatively
1-2 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Measured: 1-2 hours post operatively
1-2 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Measured: 1-2 hours post operatively
1-2 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Measured: 1-2 hours post operatively
1-2 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Measured: 1-2 hours post operatively
1-2 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Measured: 1-2 hours post operatively
2-4 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Measured: 2-4 hours post operatively
2-4 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Measured: 2-4 hours post operatively
2-4 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Measured: 2-4 hours post operatively
2-4 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Measured: 2-4 hours post operatively
2-4 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Measured: 2-4 hours post operatively
4-12 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Measured: 4-12 hours post operatively
4-12 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Measured: 4-12 hours post operatively
4-12 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Measured: 4-12 hours post operatively
4-12 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Measured: 4-12 hours post operatively
12-24 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Measured: 12-24 hours post operatively
12-24 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Measured: 12-24 hours post operatively
12-24 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Measured: 12-24 hours post operatively
12-24 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Measured: 12-24 hours post operatively
24-48 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Measured: 24-48 hours post operatively
24-48 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Measured: 24-48 hours post operatively
24-48 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Measured: 24-48 hours post operatively
24-48 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Measured: 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)
Measured: 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)
Measured: Post operative day 7-10 (Follow-up Clinic)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jul 2015

First posted3 Jun 2014 (estimated)
Study startJul 2014
Primary completionJan 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02154763
Sponsor's protocol ID: 717602410
Acronym: INOPAIN
Status last verified: Mar 2019
First submitted: 16 May 2014
Last updated: 19 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

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.
PubMed 34759045
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.
PubMed 25113556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02154763
Acronym / sponsor ID: INOPAIN / 717602410
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric surgery, Bariatrics, Local anesthetic, Ropivacaine, Intraperitoneal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: Jul 2014
Primary completion: Jan 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intraperitoneal Normal Saline	Placebo comparator	Drug: Normal SalineIntraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm
Intraperitoneal ropivacaine	Experimental	Drug: RopivacaineThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RopivacaineAlso: NAROPIN®, 84057-95-4	Drug	Intraperitoneal ropivacaine
Normal SalineAlso: Sodium Chloride, 7647-14-5	Drug	Intraperitoneal Normal Saline

Primary outcome

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

43 secondary outcomes

1h Peak Expiratory Flow (PEF) Score
Time frame: 1 hours post operatively
2h Peak Expiratory Flow (PEF) Score
Time frame: 2 hours post operatively
4h Peak Expiratory Flow (PEF) Score
Time frame: 4 hours post operatively
8h Peak Expiratory Flow (PEF) Score
Time frame: 8 hours post operatively
12h Peak Expiratory Flow (PEF) Score
Time frame: 12 hours post operatively
16h Peak Expiratory Flow (PEF) Score
Time frame: 16 hours post operatively
20h Peak Expiratory Flow (PEF) Score
Time frame: 20 hours post operatively
24h Peak Expiratory Flow (PEF) Score
Time frame: 24 hours post operatively
32h Peak Expiratory Flow (PEF) Score
Time frame: 32 hours post operatively
40h Peak Expiratory Flow (PEF) Score
Time frame: 40 hours post operatively
48h Peak Expiratory Flow (PEF) Score
Time frame: 48 hours post operatively
6 Minute Walking Distance Post Operative Day 1 (POD1)
Time frame: Post operative day 1
6 Minute Walking Distance Post Operative Day 2 (POD2)
Time frame: Post operative day 2
Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)
Time frame: Post operative day 1
0-1 h Postoperative Tylenol Consumption
Time frame: 0-1 hours post operatively
0-1 h Postoperative Ketorolac Consumption
Time frame: 0-1 hours post operatively
0-1 h Postoperative Dilaudid Consumption
Time frame: 0-1 hours post operatively
0-1 h Postoperative Tramadol Consumption
Time frame: 0-1 h Postoperative Tramadol consumption
0-1 h Postoperative Fentanyl Consumption
Time frame: 0-1 hours post operatively
1-2 h Postoperative Tylenol Consumption
Time frame: 1-2 hours post operatively
1-2 h Postoperative Ketorolac Consumption
Time frame: 1-2 hours post operatively
1-2 h Postoperative Dilaudid Consumption
Time frame: 1-2 hours post operatively
1-2 h Postoperative Tramadol Consumption
Time frame: 1-2 hours post operatively
1-2 h Postoperative Fentanyl Consumption
Time frame: 1-2 hours post operatively
2-4 h Postoperative Tylenol Consumption
Time frame: 2-4 hours post operatively
2-4 h Postoperative Ketorolac Consumption
Time frame: 2-4 hours post operatively
2-4 h Postoperative Dilaudid Consumption
Time frame: 2-4 hours post operatively
2-4 h Postoperative Tramadol Consumption
Time frame: 2-4 hours post operatively
2-4 h Postoperative Fentanyl Consumption
Time frame: 2-4 hours post operatively
4-12 h Postoperative Tylenol Consumption
Time frame: 4-12 hours post operatively
4-12 h Postoperative Ketorolac Consumption
Time frame: 4-12 hours post operatively
4-12 h Postoperative Tramadol Consumption
Time frame: 4-12 hours post operatively
4-12 h Postoperative Dilaudid Consumption
Time frame: 4-12 hours post operatively
12-24 h Postoperative Tylenol Consumption
Time frame: 12-24 hours post operatively
12-24 h Postoperative Ketorolac Consumption
Time frame: 12-24 hours post operatively
12-24 h Postoperative Tramadol Consumption
Time frame: 12-24 hours post operatively
12-24 h Postoperative Dilaudid Consumption
Time frame: 12-24 hours post operatively
24-48 h Postoperative Tylenol Consumption
Time frame: 24-48 hours post operatively
24-48 h Postoperative Ketorolac Consumption
Time frame: 24-48 hours post operatively
24-48 h Postoperative Tramadol Consumption
Time frame: 24-48 hours post operatively

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intraperitoneal Normal Saline	60	46
Intraperitoneal Ropivacaine	60	46

Primary outcome: 0-1 h Postoperative Pain Level

Time frame: 0-1 hours post operatively. Mean (Standard Deviation). Unit: units on a scale

Measure	Intraperitoneal Normal Saline n = 42	Intraperitoneal Ropivacaine n = 45
Value	3.9762 (2.5191)	4.3149 (2.1074)

Population analysed: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician

Primary outcome: 1-2 h Postoperative Pain Level

Time frame: 1-2 hours post operatively. Mean (Standard Deviation). Unit: units on a scale

Measure	Intraperitoneal Normal Saline n = 41	Intraperitoneal Ropivacaine n = 45
Value	3.5307 (1.6086)	3.6911 (1.522)

Primary outcome: 2-4 Hours Post Operative Pain Level

Time frame: 2-4 hours post operatively. Mean (Standard Deviation). Unit: units on a scale

Measure	Intraperitoneal Normal Saline n = 43	Intraperitoneal Ropivacaine n = 46
Value	3.2733 (1.3186)	3.1978 (1.1836)

Primary outcome: 4-8 Hours Post Operative Pain Level

Time frame: 4-8 hours post operatively. Mean (Standard Deviation). Unit: units on a scale

Measure	Intraperitoneal Normal Saline n = 43	Intraperitoneal Ropivacaine n = 45
Value	3.6507 (1.7729)	3.8387 (1.6156)

43 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected up to postoperative day 7. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 46 (0%)	0 of 46 (0%)	Not reported
Intraperitoneal Ropivacaine	0 of 46 (0%)	0 of 46 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34759045Jarrar 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.
Derived from this study: PubMed 25113556Wu 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Mamazza, MD principal investigator

The Ottawa Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine and Normal Saline in people with Bariatric Surgery Candidate, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

0-1 h Postoperative Pain Level (time frame: 0-1 hours post operatively). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02154763, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.