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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Lidocaine infusion |
|
| Placebo | Placebo Comparator | Placebo Normal Saline Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Infusion | Drug | 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Total Opioid Consumption | 24 hour total opioid consumption using IV morphine equivalents | 24 hours post surgery |
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Inclusion Criteria:
Exclusion Criteria:
Dropout: Conversion to open, patient or surgeon request.
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio De Oliveira, M.D | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11179243 | Background | 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. | |
| 6691724 | Background | 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. |
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60 subjects were assessed for eligibility and 9 were excluded because they did not meet inclusion criteria n=3 or the subject refused n=6.
51 subjects were randomized to the study
51 subjects were randomized and 50 completed the study. Subjects were enrolled consecutively from August 2010 through October 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period |
| FG001 | Placebo | Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period |
| BG001 | Placebo | Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | units on scale 40 (low) - 200 (high) | 24 hours |
|
24 hours after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Lidocaine infusion Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Nausea | Systematic Assessment | Nausea |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira MD | Northwestern University | 312-472-3573 | g-jr@northwestern.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period |
|
|
| 9717428 | Background | Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506. |
| 8652329 | Background | 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. |
| 3354874 | Background | Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82. |
| 10718794 | Background | 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. |
| 10910857 | Background | 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. |
| 11703235 | Background | 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. |
| 9861124 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Inter-Quartile Range | Unit of measure (kg/m2) |
|
|
|
|
| Secondary | 24 Hour Total Opioid Consumption | 24 hour total opioid consumption using IV morphine equivalents | Posted | Median | Inter-Quartile Range | miligrams | 24 hours post surgery |
|
|
|
| 0 |
| 24 |
| 5 |
| 24 |
| EG001 | Placebo | Placebo Normal Saline Infusion Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period | 0 | 26 | 14 | 26 |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |