Optimizing Recovery in Abdominoplasty

Postoperative Pain Clinical Trial

Official title:

Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04254692
• Other study ID #: 2019-1570
• Secondary ID: A539730SMPH/SURG
• Status: Suspended
• Phase: Phase 4
• Start date: January 5, 2021
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 46
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	University of Wisconsin Madison Surgery Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use at 24 hours	Amount of opioids used postoperatively, measured in morphine equivalents	24 hours postoperatively
Secondary	Quality of Recovery-40 (QOR-40) Score	The QOR-40 is a 40 item survey about the quality of recovery with a total possible range of scores from 40 to 200 where the higher the score the higher quality the recovery.	24 hours postoperatively
Secondary	Pain score Postoperative Day 1 (POD 1)	The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.	24 hours postoperatively
Secondary	Pain score 1 week postop	The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.	1 week postoperatively
Secondary	Opioid use at 1 week	total opioid used, measure in morphine equivalents	1 week postoperatively
Secondary	Antiemetic use POD 1	total antiemetic used	24 hours postoperatively
Secondary	Antiemetic use 1 week	total antiemetic used	1 week postoperatively
Secondary	Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting, as measured by frequency of emesis reported by the patient, and subjective feeling of nausea.	24 hours postoperatively
Secondary	Incidence of postoperative complications	Incidence of postoperative complications	1 week postoperatively