Surgical Pain Control With Ropivacaine by Atomized Delivery

NCT01480089 | Completed Phase 4 Results

• 1 other identifier: 203353
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine the effect of spraying a local anesthetic called Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a local anesthetic used to block pain in the body. There are studies showing that Ropivacaine decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder removal but has not been tried in robotic pelvic surgery.

Conditions

Pain

Keywords

Surgical Pain Management; Robotic surgery; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)

  Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.

  2 hours after surgery

Secondary Outcomes (1)

• Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)

  12 hours after surgery

Study Arms (2)

Atomized Intraperitoneal Saline (AIS)

PLACEBO COMPARATOR

Participants randomized to this arm will be given atomized intraperitoneal saline(AIS).

Drug: Atomized Intraperitoneal Saline (AIS)

Intraperitoneal Ropivacaine(AIR)

ACTIVE COMPARATOR

Participants randomized to this arm will receive atomized intraperitoneal ropivacaine (AIR).

Drug: Intraperitoneal Ropivacaine (AIR)

Interventions

Intraperitoneal Ropivacaine (AIR) DRUG

Ropivacaine 2 mg/kg per lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery.

Also known as: Ropivacaine

Intraperitoneal Ropivacaine(AIR)

Atomized Intraperitoneal Saline (AIS) DRUG

Atomized saline will be administered to the peritoneal cavity at the completion of surgery.

Also known as: Placebo

Atomized Intraperitoneal Saline (AIS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent to undergo robotic assisted gynecologic or urologic surgery
• Between the ages of 18 and 75
• Able to consent, fill out study documents, and complete all study procedures and follow-up visits

You may not qualify if:

• Patients with an allergy to local anesthetics
• Patients with severe underlying cardiovascular, renal or hepatic disease
• Pregnant patients

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (10)

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 BACKGROUND

• Hartog CS, Rothaug J, Goettermann A, Zimmer A, Meissner W. Room for improvement: nurses' and physicians' views of a post-operative pain management program. Acta Anaesthesiol Scand. 2010 Mar;54(3):277-83. doi: 10.1111/j.1399-6576.2009.02161.x. Epub 2009 Nov 12.

  PMID: 19912126 BACKGROUND

• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

  PMID: 22227789 BACKGROUND

• Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.

  PMID: 16931681 BACKGROUND

• Kang H, Kim BG. Intraperitoneal ropivacaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study. J Int Med Res. 2010 May-Jun;38(3):821-32. doi: 10.1177/147323001003800309.

  PMID: 20819419 BACKGROUND

• McClure JH. Ropivacaine. Br J Anaesth. 1996 Feb;76(2):300-7. doi: 10.1093/bja/76.2.300. No abstract available.

  PMID: 8777115 BACKGROUND

• Bleckner LL, Bina S, Kwon KH, McKnight G, Dragovich A, Buckenmaier CC 3rd. Serum ropivacaine concentrations and systemic local anesthetic toxicity in trauma patients receiving long-term continuous peripheral nerve block catheters. Anesth Analg. 2010 Feb 1;110(2):630-4. doi: 10.1213/ANE.0b013e3181c76a33. Epub 2009 Dec 2.

  PMID: 19955504 BACKGROUND

• Labaille T, Mazoit JX, Paqueron X, Franco D, Benhamou D. The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for laparoscopic cholecystectomy. Anesth Analg. 2002 Jan;94(1):100-5, table of contents. doi: 10.1097/00000539-200201000-00019.

  PMID: 11772809 BACKGROUND

• Mueller ER, Kenton K, Anger JT, Bresee C, Tarnay C. Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):917-21. doi: 10.1016/j.jmig.2016.05.001. Epub 2016 May 12.

  PMID: 27180224 BACKGROUND

• Collins GG, Gadzinski JA, Fitzgerald GD, Sheran J, Wagner S, Edelstein S, Mueller ER. Surgical Pain Control With Ropivacaine by Atomized Delivery (Spray): A Randomized Controlled Trial. J Minim Invasive Gynecol. 2016 Jan;23(1):40-5. doi: 10.1016/j.jmig.2015.07.018. Epub 2015 Aug 1.

  PMID: 26241686 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

There are no caveats to report.

Results Point of Contact

• Title: Elizabeth Mueller, M.D.
• Organization: Loyola University

emuelle@lumc.edu

708-216-2180

Study Officials

• Elizabeth Mueller, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 27, 2016
• Results First Posted: July 27, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)