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

NCT ID: NCT01180660

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-11-30

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.

Conditions

Pain; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Lidocaine

Lidocaine infusion

Group Type: ACTIVE_COMPARATOR

Lidocaine Infusion

Intervention Type: DRUG

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

Placebo

Placebo Normal Saline Infusion

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

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

Interventions

Lidocaine Infusion

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

Intervention Type: DRUG

Normal Saline

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

Intervention Type: DRUG

Other Intervention Names

Placebo infusion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Gildasio De Oliveira

Gildasio De Oliveira, M.D. Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gildasio De Oliveira, M.D

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11179243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6691724 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 9717428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8652329 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 3354874 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10718794 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10910857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11703235 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9861124 (View on PubMed)

Other Identifiers

STU00032300

Identifier Type: -

Identifier Source: org_study_id