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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180660
• Other study ID #: STU00032300
• Status: Completed
• Phase: N/A
• First received: July 19, 2010
• Last updated: July 15, 2014
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pain
• Pain, Postoperative

Intervention

Drug:
• Lidocaine Infusion
1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period
• Normal Saline
Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. Review. — View Citation

Møiniche 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. — View Citation

Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. Review. — View 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. — View 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. Review. — View 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. — View Citation

Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	24 Hour Total Opioid Consumption	24 hour total opioid consumption using IV morphine equivalents	24 hours post surgery	No