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Completed

NCT Number: NCT04278846

Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.

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Key information

Conditions

Pain, Postoperative Mammaplasty Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivicaine HCl (control group) or liposomal bupivacaine/Exparel (experimental group). Pain will be assessed qualitatively through the use of: 1) numeric rating scale during rest (NRS-R) and activity (NRS-A), 2) brief pain inventory (BPI) questionnaire, and 3) postoperative analgesia patient satisfaction scale. Furthermore, investigators will record the use of rescue analgesics for each patient. This part of the study will provide quantitative data that investigators can then use in comparison to the qualitative measurements (NSR, BPI, patient satisfaction scale rate). In turn, this will allow us to objectify patient's pain, thereby increasing the validity of our results. More importantly, this aspect of the investigation will enable us to study the impact that liposomal bupivacaine has in reducing the postoperative usage of opioid medications in this patient population. As this is a pilot study, a sample size of 50 total patients (25 per treatment group) is planned. This sample size should provide estimates of potential effect sizes and variability in the present setting to allow for future study planning. This study should provide adequate evidence of whether pain decreases of 15% or more are unlikely in this setting.

Investigators aim to evaluate the effectiveness of DepoFoam Bupivicaine (Exparel®) to reduce postoperative pain in breast reconstruction patients compared to the current standard treatment (bupivacaine HCl). Investigators hypothesize that patients undergoing breast reconstruction with tissue expander will achieve greater control of post-operative pain and longer lasting analgesia with the use of liposomal bupivacaine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing breast reconstruction with tissue expander

Exclusion criteria

  • history of adverse reaction to local anesthesia
  • chronic liver disease
  • history of chronic preoperative consumption of narcotics or opioids
  • history of alcohol and/or illicit drug dependence
  • undergoing combined procedures
  • diagnosed with neuromuscular/neurosensory disorder
  • positive pregnancy test
  • previous breast conservation therapy (lumpectomy with radiation treatment
  • previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
  • axillary node dissection
  • psychosis.

Treatment and study plan

Depofoam bupivacaine

Drug

The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Other names: liposomal bupivacaine, Exparel

Bupivacaine hydrochloride (HCl)

Drug

The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Other names: Marcaine

Primary outcomes

  1. 1 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 1 hour post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

  2. 8-12 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 8-12 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

  3. 24 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 24 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

  4. 36 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 36 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

  5. 48 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 48 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  6. 60 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 60 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  7. 72 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 72 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  8. 84 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 84 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  9. 96 Hour Pain Assessment Numeric Rating Scale During Rest

    Time frame: 96 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

    The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) Range 0-10

  10. 36 Hour Pain Assessment Numeric Rating Scale During Activity

    Time frame: 36 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

    The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  11. 48 Hour Pain Assessment Numeric Rating Scale During Activity

    Time frame: 48 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

    The higher scores indicate more severe pain during activity (10 meaning the worst pain,0 meaning no pain) The range is 0 to 10.

  12. 60 Hour Pain Assessment Numeric Rating Scale During Activity

    Time frame: 60 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

    The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  13. 72 Hour Pain Assessment Numeric Rating Scale During Activity

    Time frame: 72 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

    The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  14. 84 Hour Pain Assessment Numeric Rating Scale During Activity

    Time frame: 84 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

    The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  15. 96 Hour Pain Assessment Numeric Rating Scale During Activity

    Time frame: 96 hours post-operatively

    Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

    The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

  16. 24 Hour Pain Assessment Brief Pain Inventory

    Time frame: 24 hours post-operatively

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

  17. 48 Hour Pain Assessment Brief Pain Inventory

    Time frame: 48 hours post-operatively

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

  18. 72 Hour Pain Assessment Brief Pain Inventory

    Time frame: 72 hours post-operatively

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

  19. 96 Hour Pain Assessment Brief Pain Inventory

    Time frame: 96 hours post-operatively

    Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

  20. 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction

    Time frame: 96 hours post-operatively

    Pain will be assessed qualitatively through the use of post-operative analgesia patient satisfaction scale (0-5) The higher scores indicate more satisfied patients.( 5 would be very satisfied-less pain, 0 would indicate unsatisfied patients-more pain)

Secondary outcomes

  1. 24 Hour Use of Rescue Analgesic

    Time frame: 24 hours post operatively

    We will record the amount in milligrams and type of rescue analgesic for each patient.

  2. 48 Hour Use of Rescue Analgesic

    Time frame: 48 hours post operatively

    We will record the amount in milligrams and type of rescue analgesic for each patient.

  3. 72 Hour Use of Rescue Analgesic

    Time frame: 72 hours post operatively

    We will record the amount in milligrams and type of rescue analgesic for each patient.

  4. 96 Hour Use of Rescue Analgesic

    Time frame: 96 hours post operatively

    We will record the amount in milligrams and type of rescue analgesic for each patient.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Feb 20, 2020
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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