A Randomised Controlled Trial of Subacromial Local Anaesthetic Delivery Following Rotator Cuff Surgery (SALAD Trial)
A Randomised Controlled Trial Evaluating the Efficacy of Post-Operative Pain Relief Using Subacromial Local Anaesthetic Delivery Following Rotator Cuff Surgery (SALAD Trial)
Sydney Local Health District
96 participants
May 1, 2025
Interventional
Conditions
Summary
The SALAD Trial is a Randomised Controlled Trial assessing the effect of local anaesthetic delivered to the shoulder joint by a catheter inserted during surgery on post-operative pain control. Post operative pain relief makes patients more comfortable, can increase rate of recovery and reduce the risk of long-term dependence on opioid pain relief. The aim of this study is to see whether local anaesthetic delivered into the shoulder joint after surgery in addition to usual pain relief reduces pain compared to usual pain relief alone. This study is a collaboration between three departments at Royal Prince Alfred Hospital (RPAH): Department of Anaesthetics, Department of Orthopaedic Surgery, and Surgical Outcomes Research Centre (SOuRCe). All participants will undergo arthroscopic rotator cuff repair surgery followed by insertion of a subacromical cathether for the administration of local anaesthetic or placebo. The first dose of local anaesthetic or placebo is administered in the Post Anaesthesia Care Unit (PACU) as the pump is connected. Participants will be randomised to receive either local anaesthetic or placebo. We hypothesise that in patients undergoing primary arthroscopic rotator cuff repair procedures, there is a significant reduction in post-operative pain and opiate usage for patients who receive a Programmed Intermittent Bolus of Local Anaesthetic into the subacromial space via a subacromial catheter compared to patients who receive a placebo infusion into the subacromial space only.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The intervention being assessed in this trial is a Programmed Intermittent Bolus of Local Anaesthetic into the subacromial space via a subacromial catheter following primary arthroscopic rotator cuff repair procedures. The anaesthetic to be delivered through the subacromial catheter is a 200mL bag containing 0.2% ropivacaine with 12ml solution administered as a second hourly bolus. The first dose of local anaesthetic or placebo is administered in the Post Anaesthesia Care Unit (PACU) as the pump is connected to the patient. The Portex 16g epidural catheter is typically removed on day 1 post-operatively prior to patient discharge; the catheter will not be retained longer than is required for standard post-operative analgesia purposes. The standard post-operative analgesia protocol will be instituted with Fentanyl or Oxycodone Patient Controlled Anesthesia (PCA) on the ward to continue as required. Under normal circumstances, the PCA would be taken down at the Acute Pain Service (APS) visit on day 1. Most patients will be able to go home on day 1 post-operatively and will not require a PCA beyond the first 24 hours. The electronic medical record and anaesthetic administration record will be used to monitor adherence to the intervention and collect the primary outcome of milligrams of morphine or equivalent (MeQ).
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623001091695