NCT01180660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

July 19, 2010

Results QC Date

April 8, 2014

Last Update Submit

July 15, 2014

Conditions

PainObesity

Keywords

Gastric SurgeryPainRecoveryLaparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (1)

  • 24 Hour Total Opioid Consumption

    24 hours post surgery

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Lidocaine infusion

Drug: Lidocaine Infusion

Placebo

PLACEBO COMPARATOR

Placebo Normal Saline Infusion

Drug: Normal Saline

Interventions

Lidocaine InfusionDRUG

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

Lidocaine
Normal SalineDRUG

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

Also known as: Placebo infusion
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

  • 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.

    PMID: 11179243BACKGROUND

  • 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.

    PMID: 6691724BACKGROUND

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

    PMID: 9717428BACKGROUND

  • 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.

    PMID: 8652329BACKGROUND

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

    PMID: 3354874BACKGROUND

  • 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.

    PMID: 10718794BACKGROUND

  • 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.

    PMID: 10910857BACKGROUND

  • 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.

    PMID: 11703235BACKGROUND

  • 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.

    PMID: 9861124BACKGROUND

MeSH Terms

Conditions

PainObesity

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

We did not evaluate if the opioid sparing properties of systemic lidocaine resulted in a lower incidence of adverse respiratory events (hypoxemia/hypoventilation). We were underpowered to detect significant differences in certain parts of the qor-40.

Results Point of Contact

Title
Gildasio De Oliveira MD
Organization
Northwestern University
g-jr@northwestern.edu
312-472-3573

Study Officials

  • Gildasio De Oliveira, M.D

    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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

First Submitted

July 19, 2010

First Posted

August 12, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

August 7, 2014

Results First Posted

August 7, 2014

Record last verified: 2014-07

Locations

US(1)