Preoperative Oral Dexamethasone to Improve Recovery After Surgery

Breast Cancer Clinical Trial

Official title: The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery

Status Enrolling by invitation

Clinical Trial Summary

Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The investigators will also look at the effect of our intervention on post operative nausea and vomiting.

Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will also complete a Clinically significant nausea and vomiting score upon discharge from the post anesthesia recovery room, repeated at 24 hours post op.

Clinical Trial Description

Design: This will be a single centre randomized, double blind, parallel-group, intention to treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone or placebo

Group 1: Pre-operative oral dexamethasone (10mg-2 hours pre-induction) Group 2: Placebo Sample Size: 80 patients (80% power to detect a difference of 10 points in our primary endpoint)

Study duration: 8 months

Primary endpoint: Quality of recovery at 24 hours post operation, as measured on the QoR-40 Secondary endpoints: Clinically significant nausea and vomiting on discharge from Post-Anesthesia Recovery Room (PARR) and at 24 hours.

Study hypotheses:Pre-operative oral dexamethasone will improve patient quality of recovery compared to placebo.

Secondary hypothesis: Pre-operative dexamethasone will decrease clinically significant post operative nausea and vomiting in the post anesthesia recovery room and this benefit will endure at 24 hours.

Importance: Small studies in other adult populations suggest that IV dexamethasone may improve quality of recovery. IV dexamethasone is widely used off label for postoperative nausea and vomiting (PONV) prophylaxis, oral dexamethasone has not been studied for this indication but based on the pharmacodynamics of dexamethasone, and that modulation of nucleolar transcription is likely important in dexamethasone's clinical effect; an earlier administration time is likely of benefit, this could be facilitated by an oral (vs IV) route of administration. This study will provide the preliminary support (or absence of support) for a routine, inexpensive intervention to optimize patient outcome.

Background: Single, low dose perioperative dexamethasone is safe and beneficial but common timing of administration does not maximize effectiveness. IV dexamethasone improves quality of recovery in patients undergoing laparoscopic cholecystectomy and provides a potential 1.5 mm improvement in VAS pain scores in the first 6 hours post mastectomy, which is of questionable clinical significance. A study to determine if dexamethasone improves the quality of recovery in patients undergoing breast surgery is needed in order to provide evidence for change of practices and pre-operative oral dexamethasone offers the potential for routine, low cost administration without uncomfortable side effects.

Methods: Patients will be recruited pre-operatively and contacted by telephone for preliminary consent. They will receive consent documents on the morning of surgery and be randomized at that time, they will complete a pre-operative QOR-40 and receive oral dexamethasone or placebo. During their general anaesthesia (GA) they will all receive IV Ondansetron and have their blood glucose measured 2 hours after skin incision. On discharge from PARR they will have a clinically significant nausea and vomiting scale score recorded, repeated at 24 hours post op. They will also complete the QOR-40 at 24 hours post op.

Analysis: Data will be analyzed using analysis of variance, mixed models and t-tests.

Potential Pitfalls: As the QOR-40 instrument is a survey, it is prone to inter and intra patient variability. The investigators are controlling for inter-patient variability by having patients complete the instrument before surgery to collect an individual baseline. The investigators are relying on a 25% recruitment rate of eligible patients in order to complete the study in the stated timeframe. The study has an important but narrow focus, it is not feasible to perform subgroup analysis on the small study size. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT02234466
• Study type: Interventional
• Source: University of Manitoba
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: August 2014
• Completion date: June 2015