Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride

Coronary Artery Disease Clinical Trial

Official title:

Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270514
• Other study ID #: PRO17060305
• Status: Completed
• Phase: Phase 3
• Start date: November 15, 2018
• Est. completion date: February 25, 2020

Study information

• Verified date: August 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration

Description:

There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2020
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)

• Surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

• Minimally invasive heart surgery through thoracotomy approach

• Patient undergoing procedures under deep hypothermic circulatory arrest

• Patients with active infections such as infective endocarditis

• Emergency surgery

• Patients undergoing transplantations and ventricular assist device insertion

• Patients on any mechanical circulatory support preoperatively

• Patient's refusal

• End stage liver or renal disease

• Allergy to bupivacaine

• Patient who cannot understand the study procedure or refuse to participate

• Redo-sternotomy

• Participation in another study

• Patients with severe right or left ventricular dysfunction (EF< 25%)

• Patients requiring chronic opioids for chronic pain condition

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenoses
• Coronary Stenosis
• Mitral Valve Insufficiency
• Tricuspid Valve Insufficiency
• Valve Regurgitation, Mitral
• Valve Regurgitation, Tricuspid

Intervention

Drug:
• Exparel Injectable Product
Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
• Bupivacaine Hydrochloride
Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kathirvel Subramaniam	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delirium	Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)	Assessment will be administered at 48 hours post-operatively
Other	Delirium	Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)	Assessment will be administered at 72 hours post-operatively
Other	Patient Satisfaction	Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management	Given at the time of discharge up to 30 days post-operatively
Other	Chronic Pain Assessment	Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.	6 months after surgery
Other	Chronic Pain Assessment	Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.	12 months after surgery
Other	Serum Cortisol Levels	Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.	Measured 8, 48, and 72 hours post-operatively
Primary	Post-operative Pain Intensity	Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement	NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively
Primary	Total Narcotic Consumption	All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.	0-72 hours post-operative period
Secondary	Time to Extubation	The time it takes until the patient is extubated post-operatively will be measured	From the end of surgery until the patient is extubated up to 72 hours post-operatively
Secondary	Patient Time to Mobilization	The time it takes until patient ambulates will be measured	From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*
Secondary	Patient Time to Out of Bed to Chair	The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured	From time of end of surgery to time of mobilization up to 72 hours post-operatively
Secondary	Patient Time to Oral Intake	The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured	From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge
Secondary	Non-invasive Ventilation (NIV) Requirement	Episodes of NIV such as upper airway masks or similar devices will be quantified	From time of end of surgery to 72 hours post-operatively or until hospital discharge
Secondary	Re-intubation	Instances of re-intubation will be recorded	From time of end of surgery to patient discharge up to one week
Secondary	Use of Incentive Spirometry	Frequency of incentive spirometry will be measured	From time of end of surgery to 72 hours post-operatively
Secondary	Post-operative Nausea and Vomiting	Whether a patient experiences at least one episode of nausea and emesis will be measured	From time of end of surgery to 72 hours post-operatively
Secondary	Major Organ Dysfunction	Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted	From date of surgery assessed up to 30 day post-operatively
Secondary	Length of Hospital and ICU Stay	Length of both hospital and ICU stay will be measured	From date of surgery assessed up to 30 day post-operatively
Secondary	Hospital Readmission	Readmission to hospital will be noted	From end of surgery assessed up to 30 days post-operatively
Secondary	Mortality	Mortality will be noted at specific timepoints	From end of surgery assessed up to 30 days post-operatively