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IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

Primary Purpose

Pain, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lidocaine Infusion

Normal Saline

About this trial

This is an interventional prevention trial for Pain focused on measuring Gastric Surgery, Pain, Recovery, Laparoscopic Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I, II,III;
BMI > 35 kg/m2,
Age between 18-70,
Fluent in English,
Patients undergoing laparoscopic gastric bypass,
EKG within 3 months.

Exclusion Criteria:

History of allergy to local anesthetics,
History of chronic opioid use,
Pregnant patients,
History of EKG abnormalities.

Dropout: Conversion to open, patient or surgeon request.

Sites / Locations

Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

Lidocaine infusion

Placebo Normal Saline Infusion

Outcomes

Primary Outcome Measures

Quality of Recovery 40 on the Day After Surgery

Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high. The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.

Secondary Outcome Measures

24 Hour Total Opioid Consumption

24 hour total opioid consumption using IV morphine equivalents

Full Information

NCT ID

NCT01180660

First Posted

July 19, 2010

Last Updated

July 15, 2014

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01180660

Brief Title

IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

Official Title

The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery. This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Obesity

Keywords

Gastric Surgery, Pain, Recovery, Laparoscopic Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

Lidocaine infusion

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Normal Saline Infusion

Intervention Type

Drug

Intervention Name(s)

Lidocaine Infusion

Intervention Description

1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Other Intervention Name(s)

Placebo infusion

Intervention Description

Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period

Primary Outcome Measure Information:

Title

Quality of Recovery 40 on the Day After Surgery

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

24 Hour Total Opioid Consumption

Description

24 hour total opioid consumption using IV morphine equivalents

Time Frame

24 hours post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I, II,III; BMI > 35 kg/m2, Age between 18-70, Fluent in English, Patients undergoing laparoscopic gastric bypass, EKG within 3 months. Exclusion Criteria: History of allergy to local anesthetics, History of chronic opioid use, Pregnant patients, History of EKG abnormalities. Dropout: Conversion to open, patient or surgeon request.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gildasio De Oliveira, M.D

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11179243

Citation

Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. doi: 10.1053/gast.2001.22430.

Results Reference

background

PubMed Identifier

6691724

Citation

Peiser J, Lavie P, Ovnat A, Charuzi I. Sleep apnea syndrome in the morbidly obese as an indication for weight reduction surgery. Ann Surg. 1984 Jan;199(1):112-5. doi: 10.1097/00000658-198401000-00020.

Results Reference

background

PubMed Identifier

9717428

Citation

Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506.

Results Reference

background

PubMed Identifier

8652329

Citation

Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.

Results Reference

background

PubMed Identifier

3354874

Citation

Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.

Results Reference

background

PubMed Identifier

10718794

Citation

Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.

Results Reference

background

PubMed Identifier

10910857

Citation

Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.

Results Reference

background

PubMed Identifier

11703235

Citation

Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.

Results Reference

background

PubMed Identifier

9861124

Citation

Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.

Results Reference

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IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

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