Lidocaine and Outpatient Gynecologic Laparoscopy

NCT01250002 | Completed Results

• 1 other identifier: STU00025240
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Although ambulatory gynecological laparoscopy is considered to be a minimally invasive surgical procedure, only 60% of patients undergoing this procedure are satisfied with postoperative pain control. Postoperative pain can lead to physiological, immunological and psychological derangements in patients.It also has been shown to be the most common cause of hospital admission after outpatient surgery. Opioids constitute the most commonly used pain management strategy after surgery, however they have many undesirable side effects including nausea, vomiting and respiratory depression. Different strategies have been developed to decrease the amount of opioid required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown to be effective. Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose infusion. The improvement of surgical technique and anesthesia care has made major adverse outcomes infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to his normal activities is one of the most important sign of a successful outpatient procedure and it has significant economic implications. Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument. The research question for the study is; does the use of systemic perioperative lidocaine improve quality of recovery after outpatient laparoscopy?

Conditions

Pain

Keywords

Pain; MQOR 40; Lidocaine; Gynecologic; Surgery; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery 40 Score

  Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).

  24 hours post surgery

Secondary Outcomes (1)

• Opioid Consumption (Morphine Equivalents)

  24 hours

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Placebo will receive the same volume of saline infusion.

Drug: Placebo

Interventions

Placebo DRUG

Placebo will receive the same volume of saline infusion.

Placebo

Lidocaine DRUG

Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter

Lidocaine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients undergoing outpatient laparoscopic gynecologic surgery
• American society of anesthesiologists class (ASA) Physical status (PS) I and II
• Age between 18 and 64 years
• Fluent in English
• Body mass index (BMI) less than 35

You may not qualify if:

• History of allergy to local anesthetics
• History of chronic opioid use
• Pregnant patients
• Body Mass Index (BMI) greater than 35
• History of electrocardiogram (EKG) abnormalities
• Hepatic Impairment
• History of congestive heart failure
• Electrocardiogram (EKG) abnormalities
• History of heart block (subject with history of heart block)
• Current use of anti-arrhythmic medications
• Drop -Outs:
• Patient or surgeon request
• Conversion of the surgery from laparoscopic to open

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Womens Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (14)

• Lovatsis D, Jose JB, Tufman A, Drutz HP, Murphy K. Assessment of patient satisfaction with postoperative pain management after ambulatory gynaecologic laparoscopy. J Obstet Gynaecol Can. 2007 Aug;29(8):664-7. doi: 10.1016/s1701-2163(16)32552-x.

  PMID: 17714620 BACKGROUND

• Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

  PMID: 11460814 BACKGROUND

• McKay A, Gottschalk A, Ploppa A, Durieux ME, Groves DS. Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery. Anesth Analg. 2009 Dec;109(6):1805-8. doi: 10.1213/ANE.0b013e3181be371b.

  PMID: 19923506 BACKGROUND

• White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-S22. doi: 10.1213/01.ANE.0000177099.28914.A7.

  PMID: 16334489 BACKGROUND

• Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.

  PMID: 15041597 BACKGROUND

• Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.

  PMID: 9459225 BACKGROUND

• Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.

  PMID: 17197840 BACKGROUND

• Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.

  PMID: 18844267 BACKGROUND

• Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA. 1994 Aug 24-31;272(8):619-26.

  PMID: 7726894 BACKGROUND

• Guyatt GH, Cook DJ. Health status, quality of life, and the individual. JAMA. 1994 Aug 24-31;272(8):630-1. No abstract available.

  PMID: 8057520 BACKGROUND

• Watcha MF, Issioui T, Klein KW, White PF. Costs and effectiveness of rofecoxib, celecoxib, and acetaminophen for preventing pain after ambulatory otolaryngologic surgery. Anesth Analg. 2003 Apr;96(4):987-994. doi: 10.1213/01.ANE.0000053255.93270.31.

  PMID: 12651647 BACKGROUND

• Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

  PMID: 9895071 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.

  PMID: 22584558 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Quality of recovery (QOR-40) instrument validation was performed in the in-patient setting and formal validation for the outpatient setting is still lacking.

Results Point of Contact

• Title: Gildasio De Oliveira, MD
• Organization: Northwestern University

g-jr@northwestern.edu

312-926-8373

Study Officials

• Gildasio De Oliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

• First Submitted: November 27, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 26, 2014
• Results First Posted: June 21, 2013

Record last verified: 2014-06

Locations

US (1)