An interventional study of adjuvant type in Anesthesia, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment
The pain after shoulder rotator cuff repair surgery is severe due to the inflammatory reaction of tendon repair. Severe pain will reduce the patient's shoulder range of motion and delay functional recovery. The use of powerful analgesics for pain relief may also increase the chance of opiate analgesic-related side effects. Brachial plexus block with local anesthetic is widely used for pain control at the acute stage after shoulder arthroscopic surgery, but the maintenance time is often limited. Ropivacaine is a local anesthetic commonly used for brachial plexus block, and its half-life time is 11.8 hours. Clinical studies showed that using ropivacaine plus adjuvants such as dexamethasone or dexmedetomidine for brachial plexus block significantly extended the block duration, reduced postoperative pain, and reduced the use of opiate analgesics. However, the safest and most effective combination of local anesthetics remains unresolved.
This trial aims to evaluate and compare the effects of brachial plexus block using dexamethasone and dexmedetomidine combined with ropivacaine on postoperative pain control and functional recovery after arthroscopic rotator cuff repair surgery.
Shoulder joint surgery is an orthopedic surgery recognized to cause severe postoperative pain. The pain after shoulder rotator cuff repair surgery is severer than other shoulder joint surgeries due to the inflammatory reaction of tendon repair. Severe pain will reduce the patient's shoulder range of motion and delay postoperative functional recovery, and the use of powerful analgesics for pain relief may also increase the chance of side effects related to opiate analgesics. Therefore, postoperative pain control has become an important clinical issue.
Brachial plexus block with local anesthetic is widely used for pain control at the acute stage after shoulder arthroscopic surgery, but the maintenance time is often limited. Ropivacaine is a local anesthetic commonly used for brachial plexus block, and its half-life time is 11.8 hours. Clinical studies showed that using ropivacaine plus adjuvants such as dexamethasone or dexmedetomidine to perform brachial plexus block significantly extended the block duration, reduced postoperative pain, and reduced the use of opiate analgesics. Brachial plexus block with low-dose dexmedetomidine plus ropicavaine significantly prolonged analgesia by 4 hours (14 hours vs. 10 hours) compared to ropicavaine alone, and reduced the dose of opiate analgesias in the first 24 hours after surgery. Compared to ropicavaine only, low-dose dexamethasone plus ropivacaine effectively extended the analgesic duration by 8 hours (19.7 hours vs. 11.8 hours) and reduced the dose of opioid analgesics within 36 hours after surgery (6.5mg versus 2mg). Meanwhile, continuous administration of ropicavaine through a catheter for brachial plexus block can maintain effective analgesia. However, the safest and most effective combination of local anesthetics remains unresolved.
This trial aims to evaluate and compare the effects of brachial plexus block using adjuvants dexamethasone and dexmedetomidine combined with ropivacaine on postoperative pain control and functional recovery following arthroscopic rotator cuff repair surgery. Specifically, we will examine the effect of dexamethasone or dexmedetomidine alone, and in combination, on the duration of the analgesic effect of ropivacaine.
Taipei Veterans General Hospital, Taiwan is the lead sponsor of 338 studies on the registry; 74 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
0.6% ropivacaine, control
Procedure: adjuvant type
0.6% ropivacaine + 2mg dexamethasone
Procedure: adjuvant type
0.6% ropivacaine + 025ug/kg dexmedetomidine
Procedure: adjuvant type
0.6% ropivacaine + 2mg dexamethasone + 0.25/ug/kg dexmedetomidine
Procedure: adjuvant type
ropivacaine combined with adjuvant
postoperative pain evaluated by NRS
pain level by Numeric rating scale( 11 points ranging from 0 to 10; higher scores mean a worse outcome)
Time frame: postoperative 1hr (hour), 6hrs, 12hrs, 18hrs, 24hrs, 36hrs, 48hr; 3days , 7days, 14days, 30days, 60days, 180days
Start is estimated for Sep 2024; primary completion for Sep 2025, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taipei Veterans General Hospital, Taiwan →