Obesity, Pain
Conditions
Keywords
Gastric Surgery, Pain, Recovery, Laparoscopic Surgery
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.
Interventions
DRUGLidocaine Infusion
1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period
DRUGNormal Saline
Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 40 on the Day After Surgery | 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Total Opioid Consumption | 24 hours post surgery | 24 hour total opioid consumption using IV morphine equivalents |
Countries
United States
Participant flow
Recruitment details
51 subjects were randomized and 50 completed the study. Subjects were enrolled consecutively from August 2010 through October 2012.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Lidocaine infusion
Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period | 25 |
| 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 | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changed to open surgery | 1 | 0 |
Baseline characteristics
| Characteristic | Lidocaine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 26 Participants | 51 Participants |
| Body Mass Index | 47 Unit of measure (kg/m2) | 48 Unit of measure (kg/m2) | 47 Unit of measure (kg/m2) |
| Region of Enrollment United States | 25 participants | 26 participants | 51 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 24 | 14 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine | Quality of Recovery 40 on the Day After Surgery | 165 units on scale 40 (low) - 200 (high) |
| Placebo | Quality of Recovery 40 on the Day After Surgery | 146 units on scale 40 (low) - 200 (high) |
Comparison: A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.p-value: 0.0195% CI: [3, 27]Regression, Linear
Secondary
24 Hour Total Opioid Consumption
24 hour total opioid consumption using IV morphine equivalents
Time frame: 24 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine | 24 Hour Total Opioid Consumption | 26 miligrams |
| Placebo | 24 Hour Total Opioid Consumption | 36 miligrams |