Surgical Pain Control With Ropivacaine by Atomized Delivery

NCT ID: NCT01480089

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-02-28

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.

Detailed Description

Practice guidelines from the American Society of Anesthesiologists peri-operative techniques for pain management have remained essentially unchanged over the last 10 years (3). Current acute pain-management strategies include 1.) Epidural or intrathecal opioids 2.) Patient-controlled devices delivering systemic opioids and 3.) Regional techniques such as peripheral nerve blocks and post-incisional infiltration with local anesthetics.

The use of epidural and systemic opioids results in significant side-effects such as post-operative nausea and ileus which often lead to increased hospital stay. The literature supporting the benefit of preincisional infiltration with anesthetics remains equivocal.

A recently published study describes the use of intraperitoneal Ropivacaine (2mh/kg) during laparoscopic appendectomy(4). The study was a randomized, double-blinded, placebo-controlled study using Ropivacaine (vs placebo) injected through the laparoscopic ports prior to the start of the appendectomy in 63 patients(4).

Patients treated with Ropivacaine had a significant decrease in visual analog pain scores post-operatively and had decreased narcotic use during their hospital stay compared to placebo. There were no side-effects found with the one-time use of the Ropivacaine.

The results of the above study and review of an additional 24 randomized controlled trials conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port placement and the operative procedures vary significantly. Hence this study was undertaken to investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and narcotics at the time of pelvic surgery.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Atomized Intraperitoneal Saline (AIS)

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

Group Type: PLACEBO_COMPARATOR

Atomized Intraperitoneal Saline (AIS)

Intervention Type: DRUG

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

Intraperitoneal Ropivacaine(AIR)

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

Group Type: ACTIVE_COMPARATOR

Intraperitoneal Ropivacaine (AIR)

Intervention Type: 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.

Interventions

Intraperitoneal Ropivacaine (AIR)

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.

Intervention Type: DRUG

Atomized Intraperitoneal Saline (AIS)

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

Intervention Type: DRUG

Other Intervention Names

Ropivacaine; Placebo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Mueller

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12873949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19912126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22227789 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16931681 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20819419 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 8777115 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19955504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11772809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27180224 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26241686 (View on PubMed)

Other Identifiers

203353

Identifier Type: -

Identifier Source: org_study_id