Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery

Pain, Postoperative Clinical Trial

Official title:

Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine Plus Dexamethasone for Mastectomy With Immediate Reconstruction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03383198
• Other study ID #: Pro00072519
• Status: Terminated
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: August 2018
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.

Description:

This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Scheduled for bilateral mastectomy

Exclusion Criteria:

• allergy to local anesthetics, prior breast surgery, asymmetric surgical plan

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Liposomal bupivacaine right injection
Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
• Liposomal bupivacaine left injection
Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.

Locations

Country	Name	City	State
United States	Patewood Memorial Hospital	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

References & Publications (2)

Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586. — View Citation

Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Bilateral Pain Comparison	Subjective, binary question "Does one side of your chest have more surgical pain than the other?"	up to 48 hours
Secondary	Duration of Analgesia	Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale	up to 48 hours