Optimizing Recovery in Abdominoplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2021-01-21

Brief Summary

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The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of postoperative nausea and vomiting (PONV), and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in 46 participants 18 years and older undergoing elective abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

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Detailed Description

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Postoperative pain, nausea, and vomiting can be frustrating sequelae of elective surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. Despite the use of multiple techniques for managing postoperative pain in abdominoplasty patients, pain control continues to be a challenge for this patient population.

One technique commonly employed to improve pain control is the use of abdominal wall and incisional injection of local anesthetic agents to block the sensory nerves supplying the anterior abdominal wall and abdominal incisions in order to decrease sensation and pain in the abdomen in the setting of abdominoplasty surgery. Local anesthetic often used in this procedure is bupivacaine (Marcaine) ± epinephrine. However, in 2012, a liposomal bupivacaine suspension (Exparel; Pacira BioSciences, Inc, San Diego, California) was introduced as a longer-acting local anesthetic used for management of postoperative pain. At the University of Wisconsin, patients undergoing abdominoplasty routinely receive intraoperative injection of local anesthetic to the abdominal wall and abdominal incisions, using bupivacaine as the local anesthetic, along with standard multimodal perioperative pain management including cool compresses, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids.

The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of PONV, and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in patients undergoing abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Liposomal Bupivacaine

Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.

Bupivacaine

Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.

Group Type OTHER

Standard of care

Intervention Type OTHER

Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall

Interventions

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Liposomal bupivacaine

Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.

Intervention Type DRUG

Standard of care

Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).

Exclusion Criteria

* Pregnant or breast-feeding women
* Incarcerated women or men
* Individuals unable to give consent due to another condition such as impaired decision-making capacity.
* Men or women who take opioid pain medications on a regular basis prior to surgery
* Men or women with a history of opioid abuse and/or dependence
* Participants with a history of bleeding disorders precluding safe abdominoplasty
* Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist
* Participants not medically cleared for surgery at Madison Surgery Center. This would include participants with sepsis/bacteremia, significant valvular disorders or heart conditions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes