None listed
Conditions
Brief 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.
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
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).
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing primary unilateral shoulder surgery for rotator cuff repair with or without adjunct bony procedures (subacromial decompression, distal clavicle excision) Patients aged greater than or equal to 18 years of age American Society of Anesthesiologists (ASA) physical status I to III
Exclusion criteria
Undergoing revision surgery Contraindication to local anaesthetic administration Co-existent coagulopathy Chronic opioid use Cognitive impairment such that a patient is unable to independently consent to participate
Outcome results
None listed