None listed
Conditions
Brief summary
This will be a pilot study to determine efficacy of combination clonidine, adrenaline, ropivacaine, lidocaine, dexamethasone combination in reducing pain, time to first opioid analgesia, and total opioid analgesia consumption postoperatively compared with combination lidocaine and ropivacaine. We hypothesise that the combination of the above medication will contribute to a longer lasting postoperative anaesthetic effect, such that patients will be more comfortable in the 24-48 hours post surgery, requiring less usage of opiate analgesia, and a quicker return to premorbid activity and function.
Interventions
Patients will be randomly assigned to either the custom solution (CLARD) group or conventional local anaesthetic (LR) group with a 1:1 ratio. The random selection will be performed on the day of surgery by the relevant investigator, who will choose an unmarked envelope from a predetermined number of envelopes containing the assignments in a 1:1 ratio. The relevant investigator will be blinded to the selection.
The conventional local anaesthetic group will receive a combination of 10ml plain 1% r
Patients will be randomly assigned to either the custom solution (CLARD) group or conventional local anaesthetic (LR) group with a 1:1 ratio. The random selection will be performed on the day of surgery by the relevant investigator, who will choose an unmarked envelope from a predetermined number of envelopes containing the assignments in a 1:1 ratio. The relevant investigator will be blinded to the selection. The conventional local anaesthetic group will receive a combination of 10ml plain 1% ropivacaine, 2ml 10% lidgnocaine, and 8ml normal saline (0.9% per 100ml), for a total of 20ml solution, via subcutaneous local infiltration with a 20ml syringe and 21 gauge needle. The CLARD group will receive a combination of 10ml 1% ropivacaine, 2ml compromised of 10% lidgnocaine + 8mg dexamethasone + 75mcg clonidine, 2ml 1:10,000 adrenaline, and 3.5ml normal saline, for a total of 17.5ml custom solution, via subcutaneous local infiltration with a 20ml syringe and 21 gauge needle. In order for the Anaesthesiologist to be blinded, they will draw up both solutions for each case. Their anaesthetic nurse (who will not be an investigator), will then hand the Anaesthetist the randomly drawn assignment to be infiltrated. A standardised anaesthetic technique and local anaesthetic administration method – subcutaneous local infiltration around the median, radial and ulnar nerves at the level of the proximal wrist crease - will be used for all cases. The local anaesthetic will be administered to participants 5 minutes prior to the start of surgery. All other aspects of the surgical procedure including prophylactic antibiotics, surgical technique and closure will be performed in a standardized manner by a single Plastic and Reconstructive Surgeon. Postoperatively, patients will all receive the same pain management protocol on discharge, 2 tablets of Panadol Osteo three times a day regularly for 5 days then as required, and 10 tablets of Tapentadol Immediate Release 50-100mg for use 4 times a day as required. No anti-inflammatories will be provided on discharge and patients will be instructed not to take any in the post-operative study period. At their first follow up appointment 1 week postoperatively, patients will be asked to complete a VAS detailing postoperative pain, and a questionnaire outlining time to first opiate usage and total opiate usage. Patients will also be followed up in hand therapy clinic for functional testing as well as hand therapy.
Sponsors
Yi Xie - Peninsula Health
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
The study will include patients >18 years of age who will receive either open carpal tunnel release, open fasciectomy for Dupuytrens disease or both procedures in the same operation at Holmesglen Private Hospital.
Exclusion criteria
Patients who are <18 years of age, have evidence of cognitive impairment as formally diagnosed by a specialist physician or neuropsychologist, or have a history of chronic pain or chronic opioid use, or are actively taking a list of prohibited anti-inflammatory medications prior to the intervention will be excluded from the study. The list of prohibited anti-inflammatory medications includes ibuprofen, naproxen, diclofenac, and celecoxib. Patients who develop any Clavien grade complication postoperatively were will also be excluded.
Outcome results
None listed