Pain, Postoperative
Conditions
Keywords
Pain, Postoperative, Analgesia, Anesthesia, local, Abdominoplasty
Brief summary
Background & study question: Strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects, which include drowsiness, nausea, and vomiting. A key element of these strategies is wound injection with local anesthetic (numbing medicine) at the time of surgery. Local numbing procedures are used routinely in patients undergoing abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several hours. Multiple studies have shown that locally injected pain medicines achieve better pain control, less opioid use, and faster return to normal activities, such that the use of one of these local anesthetic medicines is the current standard of care. Exparel is an extended-release formulation of bupivacaine that can produce local pain relief for up to 72 hours. Studies have shown it to provide better post-operative pain control and decreased use of opioid medications when compared to patients who did not receive any local numbing agents. Exparel has been used successfully in a variety of surgical settings, including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast augmentation. Its effectiveness has by and large been established in comparison to no local anesthetic. In this study, we seek to investigate the benefit of Exparel compared to standard bupivacaine infiltration in patients undergoing abdominoplasty. Study design: Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in this study. Consenting patients will be randomly assigned to standard bupivacaine or Exparel by coin toss after their clinic visit. On the day of surgery, the only difference between patients assigned to one arm or the other is the local anesthetic used. The surgery itself and plan for general anesthesia will be similar. Both groups will have the same pain medicines available after surgery. Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic needs for 3 days after surgery. For patients admitted after surgery, oral and IV narcotic use will be collected from their inpatient medical record. The primary outcome of interest is daily and cumulative pain scores through 3 days. A secondary endpoint is daily and total opioid use over 3 days. Additional measures include the time to first post-operative use of opioid medication and incidence of any adverse side effects.
Interventions
DRUGLiposomal Injection Bupivacaine (Exparel)
DRUGStandard bupivicaine
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult men and women * scheduled for abdominoplasty
Exclusion criteria
* pregnant women * patients with allergy to amide-type local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, Visual Analogue Pain Scores | 3 days | Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at Emory University Hospital - Midtown between October 2013 through November 2013.
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Injection Bupivicaine (Exparel) Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel) | 4 |
| Standard Bupivicaine Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine | 0 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 4 | 0 |
Baseline characteristics
| Characteristic | Liposomal Injection Bupivicaine (Exparel) | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 4 participants | 4 participants |
| Gender Female | 4 participants | 4 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 4 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 | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
Primary
Pain Score, Visual Analogue Pain Scores
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.
Time frame: 3 days