Clinical trial NCT01480089: Surgical Pain Control With Ropivacaine by Atomized Delivery
Official title: Surgical Pain Control With Ropivacaine by Atomized Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Surgical Pain Management
Robotic surgery
Ropivacaine
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2011-11-28
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)
timeFrame: 2 hours after surgery
Secondary outcomes:
measure: Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)
timeFrame: 12 hours after surgery
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Elizabeth Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: McClure JH. Ropivacaine. Br J Anaesth. 1996 Feb;76(2):300-7. doi: 10.1093/bja/76.2.300. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.