Bariatric Surgical Pain
Conditions
Brief summary
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.
Interventions
DRUGLidocaine
DRUGPlacebo
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients between the ages of 18-65 years old * BMI ≥ 40 kg/m2, ≤ 60 kg/m2 * Undergoing a primary laparoscopic RYGB by Dr. Murr * Agree to be followed 24 hours postoperatively * Normal K+ and Mg++ serum levels
Exclusion criteria
* BMI less than 40 kg/m2, \> 60 kg/m2 * Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr * Allergy to lidocaine * Allergy to hydromorphone or ketorolac * Allergy to corn or amide anesthetics * Use of (thioridizine) * Pregnancy * Abnormalities of ALT or AST * Intra-operative diagnosis of cirrhosis or portal hypertension * Intraoperative complications per surgeon * Intraoperative extensive adhesions per surgeon * Chronic pain syndrome and chronic use of narcotics * Severe back pain secondary to degenerative joint disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 6 hours post-surgery | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Patients received 2mg/kg/hr of lidocaine intraoperatively from the time of induction until the time of emergence. | 10 |
| Placebo Arm Patients received 2mg/kg/hr of placebo (saline) intraoperatively from the time of induction until the time of emergence. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Arm | Placebo Arm | Total |
|---|---|---|---|
| Age, Continuous Age | 47.3 years STANDARD_DEVIATION 8.3 | 47.5 years STANDARD_DEVIATION 7.4 | 47.4 years STANDARD_DEVIATION 7.8 |
| BMI | 46.4 kg/m^2 STANDARD_DEVIATION 6.1 | 48.3 kg/m^2 STANDARD_DEVIATION 5.6 | 47.5 kg/m^2 STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 10 | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Time frame: 6 hours post-surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lidocaine | Postoperative Pain | Resting VAS | 3 units on a scale |
| Lidocaine | Postoperative Pain | Coughing VAS | 8 units on a scale |
| Lidocaine | Postoperative Pain | Moving VAS | 8 units on a scale |
| Placebo | Postoperative Pain | Resting VAS | 4.5 units on a scale |
| Placebo | Postoperative Pain | Coughing VAS | 8 units on a scale |
| Placebo | Postoperative Pain | Moving VAS | 8 units on a scale |
Primary
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Time frame: 12 hours post-surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lidocaine | Postoperative Pain | Resting VAS | 3.5 units on a scale |
| Lidocaine | Postoperative Pain | Coughing VAS | 7 units on a scale |
| Lidocaine | Postoperative Pain | Moving VAS | 8 units on a scale |
| Placebo | Postoperative Pain | Resting VAS | 4 units on a scale |
| Placebo | Postoperative Pain | Coughing VAS | 7 units on a scale |
| Placebo | Postoperative Pain | Moving VAS | 7 units on a scale |
Primary
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Time frame: 18 hours post-surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lidocaine | Postoperative Pain | Resting VAS | 2.5 units on a scale |
| Lidocaine | Postoperative Pain | Coughing VAS | 6 units on a scale |
| Lidocaine | Postoperative Pain | Moving VAS | 6 units on a scale |
| Placebo | Postoperative Pain | Resting VAS | 4.5 units on a scale |
| Placebo | Postoperative Pain | Coughing VAS | 6.5 units on a scale |
| Placebo | Postoperative Pain | Moving VAS | 7 units on a scale |
Primary
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Time frame: 24 hours post-surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lidocaine | Postoperative Pain | Resting VAS | 3 units on a scale |
| Lidocaine | Postoperative Pain | Coughing VAS | 8 units on a scale |
| Lidocaine | Postoperative Pain | Moving VAS | 6 units on a scale |
| Placebo | Postoperative Pain | Moving VAS | 4.5 units on a scale |
| Placebo | Postoperative Pain | Resting VAS | 3.5 units on a scale |
| Placebo | Postoperative Pain | Coughing VAS | 5.5 units on a scale |