Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | March 2019 |
| End Date: | December 2021 |
| Contact: | Eleni Tousimis, MD |
| Email: | eleni.a.tousimis@gunet.georgetown.edu |
| Phone: | 202-444-8595 |
Single-Blinded, Randomized Assessment of Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo
This is a randomized, single-blinded placebo-controlled trial.
Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at
the end of the operation, (2) injection of standard bupivacaine at the end of the operation,
or (3) no injection of local anesthetic. All patients will be able to receive IV and oral
narcotic medications in the postoperative period on an as-needed basis.
If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's
direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with
various amounts of normal saline to cover the appropriate surgical field. Our routine
expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In
our practice,we use an 18-gauge needle to inject the medication in a "field-effect"
encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by
injecting around the edges of the skin incision and drain site. This occurs prior to
dissection of the pectoralis muscle and implant or tissue expander placement.
Patients randomized to the SB arm will receive weight-based dosing of bupivacaine,
administered in the same manner as the LB arm.
Patients who are in the placebo arm will have a similar volume of saline injected into the
operative site.
Postoperatively, all patients will be kept in the hospital for at least one night. Total
length of stay will be documented. They will all have the option of receiving IV morphine
injections as well as oral acetaminophen-hydrocodone as needed for additional pain control.
The administration of these additional medications will be recorded for each patient.
On postoperative day 1, each patient will be administered the American Pain Society Outcome
Questionnaire while in the hospital. After discharge from the hospital, we will call the
patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the
same questions each time. For any patients staying in the hospital longer than 1 day, the
questionnaire will be administered in the hospital on the same postoperative days. Subject
participation only lasts for these 7 days of follow up.
Patients will be randomized to one of three arms: (1) injection of liposomal bupivacaine at
the end of the operation, (2) injection of standard bupivacaine at the end of the operation,
or (3) no injection of local anesthetic. All patients will be able to receive IV and oral
narcotic medications in the postoperative period on an as-needed basis.
If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's
direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with
various amounts of normal saline to cover the appropriate surgical field. Our routine
expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In
our practice,we use an 18-gauge needle to inject the medication in a "field-effect"
encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by
injecting around the edges of the skin incision and drain site. This occurs prior to
dissection of the pectoralis muscle and implant or tissue expander placement.
Patients randomized to the SB arm will receive weight-based dosing of bupivacaine,
administered in the same manner as the LB arm.
Patients who are in the placebo arm will have a similar volume of saline injected into the
operative site.
Postoperatively, all patients will be kept in the hospital for at least one night. Total
length of stay will be documented. They will all have the option of receiving IV morphine
injections as well as oral acetaminophen-hydrocodone as needed for additional pain control.
The administration of these additional medications will be recorded for each patient.
On postoperative day 1, each patient will be administered the American Pain Society Outcome
Questionnaire while in the hospital. After discharge from the hospital, we will call the
patient on postoperative day 2, 3, 5 and 7 to assess pain and satisfaction scores, using the
same questions each time. For any patients staying in the hospital longer than 1 day, the
questionnaire will be administered in the hospital on the same postoperative days. Subject
participation only lasts for these 7 days of follow up.
Inclusion Criteria:
1. All female patients over 18
2. Subjects must be scheduled to undergo bilateral therapeutic or prophylactic skin or
nipple-sparing mastectomy at Medstar Georgetown University Hospital
3. Subjects must have immediate reconstruction consisting of either tissue expander
placement or direct implant placement at the time of mastectomy
4. subjects are capable of giving informed consent
Exclusion Criteria:
1. Subjects cannot be homeless persons
2. Subjects cannot have active drug/alcohol dependence or abuse history.
3. Subjects cannot be pregnant
4. Subjects cannot have documented chronic or recent opioid use as well as chronic pain
syndromes
5. We will exclude any patients who will plan to undergo postoperative whole breast
radiation
6. Subjects cannot have bupivacaine (and all related analog) allergies
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