Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601647
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Efficacy of Different Adjuvants With Ropivacaine in Brachial Plexus Block on Anthroscopic Rotator Cuff Repair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Double-blind Study Effects of Different Adjuvants Combined With Ropivacaine in Interscalene Block on Postoperative Outcomes After Arthroscopic Rotator Cuff Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pain after shoulder rotator cuff repair surgery is severe due to the inflammatory reaction of tendon repair Severe pain will reduce the patients 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 118 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
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
Detailed Description:
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 patients 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 118 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 197 hours vs 118 hours and reduced the dose of opioid analgesics within 36 hours after surgery 65mg 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
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 118 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 197 hours vs 118 hours and reduced the dose of opioid analgesics within 36 hours after surgery 65mg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None