Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519584
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2007-08-21
Brief Title:
Interscalene Nerve Blocks With Ropivacaine Alone With Dexamethasone Plus Systemic Dexamethasone
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Duration of Interscalene Nerve Blocks With Ropivacaine Alone Ropivacaine Mixed With Dexamethasone and Ropivacaine Alone Combined With Systemic Dexamethasone
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Collected study data was not usable due to process miscommunications
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ropivacaine
Brief Summary:
This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone
Detailed Description:
This study proposes to recruit 120 patients who are undergoing open shoulder surgery Patients will be identified preoperatively by means of the surgical schedule at each participating location Randomization will be generated by a web-based system and stratified by hospital The attending physician will be blinded to the contents of the supplied syringes Treatment assignments consist of three groups
Ropivacaine 30 ml 05 ropivacaine plus 2 ml 09 saline local placebo for interscalene block and 09 saline 2 ml systemic placebo for intravenous injection with sedation for the block
Ropivacaine and local steroid 30 ml 05 ropivacaine plus dexamethasone 8 mg 2 ml mixed with the local anesthetic and 09 saline 2ml systemic placebo for intravenous injection with sedation for the block
bupivacaine and systemic steroid 30 ml 05 ropivacaine plus 2 ml 09 saline local placebo for interscalene block plus dexamethasone 8 mg 2 ml administered intravenously with sedation administered for the block
bupivacaine and local steroid 30 ml 05 ropivacaine plus dexamethasone 8 mg 2 ml mixed with the local anesthetic and 09 saline 2ml systemic placebo for intravenous injection with sedation for the block
All solutions for interscalene block will contain epinephrine 1400000 as a marker for intravascular injection Insulated needles with nerve stimulation will be used Motor response in the surgical limb at a current of 04 mA at 01 msec duration will be considered evidence of adequate needle position
Patients will be evaluated at 5-minute intervals for 15 minutes for development of sensory and motor block Sensory block will be assessed by loss of sensation to pinprick over the deltoid muscle Motor block will be assessed by evaluation of ability to abduct the shoulder the so-called deltoid sign During surgery patients will receive either general anesthesia or sedation at the discretion of the attending anesthesiologist
Demographic variables morphometric measurements and the specific type of procedure will be recorded The intraoperative management strategy ie general anesthesia versus sedation and the total doses of fentanyl midazolam morphine and propofol administered perioperatively will be recorded Finger-stick blood glucose will be measured upon arrival in the postanesthesia care unit PACU The primary outcome will be the duration of the interscalene nerve block which will be measured by time from onset of sensory block until first administration of analgesic medication
The severity of postoperative pain will be assessed by a blinded observer using a verbal response score VRS at 10-minute intervals for 30 minutes in the PACU Patients reporting pain scores greater than 2 will be given intravenous morphine 1-2 mg every 5 minutes until they are comfortable After discharge from the PACU pain unrelieved by oral medication VRS persistently greater than 4 will be treated with intravenous morphine Outpatients will receive a prescription for oral acetaminophen with oxycodone
A blinded observer will interview patients each morning for three days postoperatively Data collected will include time of block durationthe primary outcome defined as time from onset of sensory blockade to first administration of supplemental analgesic medication after PACU discharge as well as secondary outcomes time to a significant increase in shoulder discomfort time to a noticeable decrease in numbness andor weakness maximum VRS with rest and movement and total opioid consumption
The times and VRS scores for secondary outcomes will be based on patient reporting of the corresponding events daily A member of the study staff will contact patients at 14 days postoperatively to assess for any late or persistent complications such as residual sensory or motor block
Ropivacaine 30 ml 05 ropivacaine plus 2 ml 09 saline local placebo for interscalene block and 09 saline 2 ml systemic placebo for intravenous injection with sedation for the block
Ropivacaine and local steroid 30 ml 05 ropivacaine plus dexamethasone 8 mg 2 ml mixed with the local anesthetic and 09 saline 2ml systemic placebo for intravenous injection with sedation for the block
bupivacaine and systemic steroid 30 ml 05 ropivacaine plus 2 ml 09 saline local placebo for interscalene block plus dexamethasone 8 mg 2 ml administered intravenously with sedation administered for the block
bupivacaine and local steroid 30 ml 05 ropivacaine plus dexamethasone 8 mg 2 ml mixed with the local anesthetic and 09 saline 2ml systemic placebo for intravenous injection with sedation for the block
All solutions for interscalene block will contain epinephrine 1400000 as a marker for intravascular injection Insulated needles with nerve stimulation will be used Motor response in the surgical limb at a current of 04 mA at 01 msec duration will be considered evidence of adequate needle position
Patients will be evaluated at 5-minute intervals for 15 minutes for development of sensory and motor block Sensory block will be assessed by loss of sensation to pinprick over the deltoid muscle Motor block will be assessed by evaluation of ability to abduct the shoulder the so-called deltoid sign During surgery patients will receive either general anesthesia or sedation at the discretion of the attending anesthesiologist
Demographic variables morphometric measurements and the specific type of procedure will be recorded The intraoperative management strategy ie general anesthesia versus sedation and the total doses of fentanyl midazolam morphine and propofol administered perioperatively will be recorded Finger-stick blood glucose will be measured upon arrival in the postanesthesia care unit PACU The primary outcome will be the duration of the interscalene nerve block which will be measured by time from onset of sensory block until first administration of analgesic medication
The severity of postoperative pain will be assessed by a blinded observer using a verbal response score VRS at 10-minute intervals for 30 minutes in the PACU Patients reporting pain scores greater than 2 will be given intravenous morphine 1-2 mg every 5 minutes until they are comfortable After discharge from the PACU pain unrelieved by oral medication VRS persistently greater than 4 will be treated with intravenous morphine Outpatients will receive a prescription for oral acetaminophen with oxycodone
A blinded observer will interview patients each morning for three days postoperatively Data collected will include time of block durationthe primary outcome defined as time from onset of sensory blockade to first administration of supplemental analgesic medication after PACU discharge as well as secondary outcomes time to a significant increase in shoulder discomfort time to a noticeable decrease in numbness andor weakness maximum VRS with rest and movement and total opioid consumption
The times and VRS scores for secondary outcomes will be based on patient reporting of the corresponding events daily A member of the study staff will contact patients at 14 days postoperatively to assess for any late or persistent complications such as residual sensory or motor block
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