RecruitingPhase 4ACTRN12623001091695

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)


Sponsor

Sydney Local Health District

Enrollment

96 participants

Start Date

May 1, 2025

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Rotator cuff surgery involves repairing torn tendons in the shoulder and is a common but painful procedure. Managing pain effectively after surgery is important for both comfort and recovery, and reducing the need for strong opioid painkillers (which can have side effects and addiction risks) is a priority. This trial — called SALAD — is testing whether continuously delivering a local anaesthetic (numbing medicine) directly into the shoulder joint through a small tube placed during surgery reduces pain and opioid use after the operation compared to a placebo (saltwater). Participants will be randomly assigned to receive either local anaesthetic or placebo through the catheter in the days following surgery. Pain levels, the amount of opioid medication needed, and quality of recovery on the day after surgery will be measured and compared between the two groups. You may be eligible if you are 18 or older, are having primary (first-time) keyhole rotator cuff repair surgery at Royal Prince Alfred Hospital in Sydney, and are in a reasonable general health category (ASA I to III). People having revision surgery, with blood clotting problems, who use opioids long-term, or who have cognitive impairment affecting their ability to consent are not eligible.

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.

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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

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)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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ACTRN12623001091695


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