The effect of chitosan-dextran (Chitodex) gel with budesonide and ropivacaine on pain and wound healing following endoscopic sinus surgery

Phase 1

Recruiting

• Conditions: Chronic Rhinosinusitis; Respiratory - Other respiratory disorders / diseases; Anaesthesiology - Pain management

• Registration Number: ACTRN12615000276550
• Lead Sponsor: The Department of ENT, University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients with chronic rhinosinusitis undergoing endoscopic sinus surgery

Exclusion Criteria

Pregnanct and/or breastfeeding.
Allergy or previous adverse reaction to shellfish, anaesthetics or corticosteroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain after endoscopic sinus surgery as determined by numerical rating scale. [Pain scores will be collected at pre-determined time points for a week following the surgery. <br><br>The time-points are as follows:<br>- 2 hours after the procedure<br>- 12 hours after the procedure<br>- 24 hours after the procedure<br>- 2 days after the procedure<br>- 3 days after the procedure<br>- 4 days after the procedure<br>- 5 days after the procedure<br>- 6 days after the procedure<br>- 7 days after the procedure]

Secondary Outcome Measures

Name	Time	Method
Presence and magnitude of adhesions using an ordinal scale following endoscopic sinus surgery, as determined by endoscopic video recordings of the sinuses by the treating surgeon. [Endoscopic video recording will occur at 2 weeks, 8 weeks and 3 months following endoscopic sinus surgery. ]