Obesity, Pain, Surgery
Conditions
Keywords
TAP Block, Pain, Obesity, Surgery, Laparoscopic Banding
Brief summary
The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.
Interventions
DRUGPlacebo
Bilateral TAP block using sterile normal saline.
DRUG(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 years * BMI \>35 Kg/m2 * Surgery: laparoscopic gastric bypass surgery * ASA status: I, II and III * Fluent in English
Exclusion criteria
* History of allergy to local anesthetics * Chronic opioid use * Pregnant patients * Patients who remained intubated after surgery Drop-out criteria: Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 40 Score | 24 hours post operatively | Quality of Recovery 40 Score at 24 hours postoperative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Total Opioid Consumption. | 24 hours | 24 Hour total opioid consumption translated into IV morphine equivalents. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled consecutively from 03/2010 through 07/2012 in the pre operative area of the hospital.
Pre-assignment details
26 were assessed for eligibility. 7 were excluded ( 4 did not meet inclusion criteria and 3 refused to participate).
Participants by arm
| Arm | Count |
|---|---|
| Placebo (control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline. | 9 |
| Active Comparator (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side. | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | Placebo | Active Comparator | 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 | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 50 years | 47 years | 48 years |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 9 | 1 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Quality of Recovery 40 Score
Quality of Recovery 40 Score at 24 hours postoperative.
Time frame: 24 hours post operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Quality of Recovery 40 Score | 170 units on scale 40 (low) - 200 (high) |
| Active Comparator | Quality of Recovery 40 Score | 175.5 units on scale 40 (low) - 200 (high) |
p-value: 0.0590% CI: [-26, 3]Wilcoxon (Mann-Whitney)
Secondary
24 Hour Total Opioid Consumption.
24 Hour total opioid consumption translated into IV morphine equivalents.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | 24 Hour Total Opioid Consumption. | 13 miligram IV morphine equivalents |
| Active Comparator | 24 Hour Total Opioid Consumption. | 7.5 miligram IV morphine equivalents |