The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery

NCT02154763 | Completed Phase 3 Results DMC

• 1 other identifier: 717602410
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgery; Bariatrics; Local anesthetic; Ropivacaine; Intraperitoneal

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (43)

• 1h Peak Expiratory Flow (PEF) Score

  1 hours post operatively

• 2h Peak Expiratory Flow (PEF) Score

  2 hours post operatively

• 4h Peak Expiratory Flow (PEF) Score

  4 hours post operatively

• 8h Peak Expiratory Flow (PEF) Score

  8 hours post operatively

• 12h Peak Expiratory Flow (PEF) Score

  12 hours post operatively

Study Arms (2)

Intraperitoneal Normal Saline

PLACEBO COMPARATOR

Intraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm

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.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Also known as: NAROPIN®, 84057-95-4

Intraperitoneal ropivacaine

Normal Saline DRUG

Also known as: Sodium Chloride, 7647-14-5

Intraperitoneal Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

• 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.

  PMID: 34759045 DERIVED

• 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.

  PMID: 25113556 DERIVED

MeSH Terms

Interventions

Ropivacaine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr.Joseph Mamazza
• Organization: The Ottawa Hospital

jmamazza@toh.on.ca

613-798-5555

Study Officials

• Joseph Mamazza, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: June 3, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 19, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-03

Locations

CA (1)