Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Condition: Pain, Postoperative; Mammaplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Dexamethasone 4mg; Saline
Intervention type(s): Drug; Drug
Intervention description(s): The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.; The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment