Clinical trial NCT04919317: Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Official title: Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Mammaplasty
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
Primary purpose: TREATMENT

Brief summary: The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.

Detailed description: The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.

Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.

The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-80
* Bilateral reduction mammaplasty
* American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
* Must choose to receive preoperative nerve block as part of pain management strategy

Exclusion Criteria:

* Allergy to dexamethasone or bupivacaine
* History of postoperative nausea and vomiting following anesthesia
* History of chronic pain conditions
* History of narcotic abuse or dependency
* History of chronic renal disease
* History of chronic liver disease

Primary outcomes:
measure: Initial Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
measure: 4-hour Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 8-hour Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 12-hour Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 16-hour Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 20-hour Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 24-hour Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: Narcotic Consumption
timeFrame: Up to 24 hours postoperatively
Secondary outcomes:
measure: Initial Blood Pressure
timeFrame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
measure: 4-hour Blood Pressure
timeFrame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 8-hour Blood Pressure
timeFrame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 12-hour Blood Pressure
timeFrame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 16-hour Blood Pressure
timeFrame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 20-hour Blood Pressure
timeFrame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 24-hour Blood Pressure
timeFrame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: Initial Oxygen Saturation
timeFrame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
measure: 4-hour Oxygen Saturation
timeFrame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 8-hour Oxygen Saturation
timeFrame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 12-hour Oxygen Saturation
timeFrame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 16-hour Oxygen Saturation
timeFrame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 20-hour Oxygen Saturation
timeFrame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: 24-hour Oxygen Saturation
timeFrame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
measure: Number of Patients Administered Anti-emetics at 4-hour Intervals
timeFrame: Initial, 4, 8, 12, 16, 20, and 24 hours
measure: Short-form 36-item (Sf-36) Quality of Life Questionnaire
timeFrame: 1 week to 2 months postoperatively
measure: Rate of Wound Complications
timeFrame: 1 week to 2 months postoperatively
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Lewis Katz School of Medicine at Temple University
name: Andrew A Gassman, MD, FACS
role: PRINCIPAL_INVESTIGATOR
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