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Completed

NCT Number: NCT04919317

Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

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.

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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–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dexamethasone 4mg

Drug

The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

Saline

Drug

The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

Primary outcomes

  1. Initial Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  2. 4-hour Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  3. 8-hour Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  4. 12-hour Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  5. 16-hour Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  6. 20-hour Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  7. 24-hour Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

  8. Narcotic Consumption

    Time frame: Up to 24 hours postoperatively

    Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization

Secondary outcomes

  1. Initial Blood Pressure

    Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  2. 4-hour Blood Pressure

    Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  3. 8-hour Blood Pressure

    Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  4. 12-hour Blood Pressure

    Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  5. 16-hour Blood Pressure

    Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  6. 20-hour Blood Pressure

    Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  7. 24-hour Blood Pressure

    Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

    Systolic blood pressure

  8. Initial Oxygen Saturation

    Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  9. 4-hour Oxygen Saturation

    Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  10. 8-hour Oxygen Saturation

    Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  11. 12-hour Oxygen Saturation

    Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  12. 16-hour Oxygen Saturation

    Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  13. 20-hour Oxygen Saturation

    Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  14. 24-hour Oxygen Saturation

    Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

    SpO2 as measured by pulse oximetry

  15. Number of Patients Administered Anti-emetics at 4-hour Intervals

    Time frame: Initial, 4, 8, 12, 16, 20, and 24 hours

    Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals

  16. Short-form 36-item (Sf-36) Quality of Life Questionnaire

    Time frame: 1 week to 2 months postoperatively

    Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.

  17. Rate of Wound Complications

    Time frame: 1 week to 2 months postoperatively

    Assessment of wound complications during any postoperative clinic visit

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2021
Registry last updated
Oct 11, 2023

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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