Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402149
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-10
First Post:
2023-04-13
Brief Title:
Comparison of 2 Different Methods in Infraclavicular Block
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Comparison of 2 Different Methods in Infraclavicular Block
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The investigators wanted to see if dexamethasone which is routinely used as an adjuvant tool by different anesthesiologists in the orthopedics operating room can really start the effect of other local anesthetics early and prolong the duration of action during infraclavicular block and giving less additional analgesics after surgery
AimsThe investigators plan to determine whether this outcome of dexamethasone which is routinely used as an adjuvant tool to prolong postoperative analgesia
Methods 60 participants will be included in the study It includes participants the age of 18 who do not have lung disease such as COPD Chronic Obstructive Pulmonary Disease who will undergo infraclavicular block and who are mentally healthy with ASA I-IIIAfter obtaining written consent from the premedication unit from the participants who were preoperatively evaluated a vascular access will be opened in the non-operated arm and 009 NaCl will be started and 005 mgkg midazolam will be given All patients will be monitored With nasal cannula 3ltmin O2 will be started 3ltmin O2 will be started with nasal cannula Patients who underwent infraclavicular block by lateral sagittal method under USGultrasound guidance by adding 2ml dexamethasone 8mg 3cc 09 NaCl to local anesthetic containing 10 ml of bupivacaine 05 and 5cc of prilocaine 2 will be included in Group I Patients who underwent infraclavicular block by lateral sagittal method by adding 10 ml of Bupivacaine 05 and 5ml of prilocaine 2 and 5 cc of 09 NaCl will be included in Group II
ASA score of the patients drugs used in surgery name of surgery age weight height block time surgery start and end time pre-block vitals post-block vitals adverse effects sensory and motor block scale with 10-minute intervals after the block after the operation grades immediately after 12 hours and 24 hours VAS scoring at 12 and 24 hours after surgery surgeon satisfaction will be recorded In addition morphine and other analgesic consumption will be checked in all patients in the first 24 hours after surgery
AimsThe investigators plan to determine whether this outcome of dexamethasone which is routinely used as an adjuvant tool to prolong postoperative analgesia
Methods 60 participants will be included in the study It includes participants the age of 18 who do not have lung disease such as COPD Chronic Obstructive Pulmonary Disease who will undergo infraclavicular block and who are mentally healthy with ASA I-IIIAfter obtaining written consent from the premedication unit from the participants who were preoperatively evaluated a vascular access will be opened in the non-operated arm and 009 NaCl will be started and 005 mgkg midazolam will be given All patients will be monitored With nasal cannula 3ltmin O2 will be started 3ltmin O2 will be started with nasal cannula Patients who underwent infraclavicular block by lateral sagittal method under USGultrasound guidance by adding 2ml dexamethasone 8mg 3cc 09 NaCl to local anesthetic containing 10 ml of bupivacaine 05 and 5cc of prilocaine 2 will be included in Group I Patients who underwent infraclavicular block by lateral sagittal method by adding 10 ml of Bupivacaine 05 and 5ml of prilocaine 2 and 5 cc of 09 NaCl will be included in Group II
ASA score of the patients drugs used in surgery name of surgery age weight height block time surgery start and end time pre-block vitals post-block vitals adverse effects sensory and motor block scale with 10-minute intervals after the block after the operation grades immediately after 12 hours and 24 hours VAS scoring at 12 and 24 hours after surgery surgeon satisfaction will be recorded In addition morphine and other analgesic consumption will be checked in all patients in the first 24 hours after surgery
Detailed Description:
Background The investigators to see if dexamethasone which is routinely used as an adjuvant tool by different anesthesiologists in the orthopedics operating room can really start the effect of other local anesthetics early and prolong the duration of action during infraclavicular block thus enabling the surgery to start early and giving less additional analgesics after surgery
AimsThe investigators plan to determine whether this outcome of dexamethasone which is routinely used as an adjuvant tool to prolong postoperative analgesia
Methods 60 participants will be included in the study It includes participants over the age of 18 who do not have lung disease such as COPD Chronic Obstructive Pulmonary Disease who will undergo infraclavicular block and who are mentally healthy with ASA I-IIIAfter obtaining written consent from the premedication unit from the participants were preoperatively evaluated a vascular access will be opened in the non-operated arm and 009 NaCl will be started and 005 mgkg midazolam will be given All participants will be monitored With nasal cannula 3ltmin O2 will be started 3ltmin O2 will be started with nasal cannula Participants who underwent infraclavicular block lateral sagittal method under USG guidance by adding 2ml dexamethasone 8mg 3cc 09 NaCl to local anesthetic containing 10 ml of bupivacaine 05 and 5cc of prilocaine 2 will be included in Group I Participants underwent infraclavicular block by lateral sagittal method by adding 10 ml of Bupivacaine 05 and 5ml of prilocaine 2 and 5 cc of 09 NaCl will be included in Group II
ASA score of the participants drugs used in surgery name of surgery age weight height block time surgery start and end time pre-block vitals post-block vitals adverse effects sensory and motor block scale with 10-minute intervals after the block after the operation grades immediately after 12 hours and 24 hours VAS Visual Analogue Scale scoring at 12 and 24 hours after surgery surgeon satisfaction will be recordedIn addition morphine and other analgesic consumption will be checked in all patients in the first 24 hours after surgery
At the end of the study statistical analysis will be made parametrically and non-parametrically through the SPSS 2021 program Statistics consultancy will be taken when necessary
AimsThe investigators plan to determine whether this outcome of dexamethasone which is routinely used as an adjuvant tool to prolong postoperative analgesia
Methods 60 participants will be included in the study It includes participants over the age of 18 who do not have lung disease such as COPD Chronic Obstructive Pulmonary Disease who will undergo infraclavicular block and who are mentally healthy with ASA I-IIIAfter obtaining written consent from the premedication unit from the participants were preoperatively evaluated a vascular access will be opened in the non-operated arm and 009 NaCl will be started and 005 mgkg midazolam will be given All participants will be monitored With nasal cannula 3ltmin O2 will be started 3ltmin O2 will be started with nasal cannula Participants who underwent infraclavicular block lateral sagittal method under USG guidance by adding 2ml dexamethasone 8mg 3cc 09 NaCl to local anesthetic containing 10 ml of bupivacaine 05 and 5cc of prilocaine 2 will be included in Group I Participants underwent infraclavicular block by lateral sagittal method by adding 10 ml of Bupivacaine 05 and 5ml of prilocaine 2 and 5 cc of 09 NaCl will be included in Group II
ASA score of the participants drugs used in surgery name of surgery age weight height block time surgery start and end time pre-block vitals post-block vitals adverse effects sensory and motor block scale with 10-minute intervals after the block after the operation grades immediately after 12 hours and 24 hours VAS Visual Analogue Scale scoring at 12 and 24 hours after surgery surgeon satisfaction will be recordedIn addition morphine and other analgesic consumption will be checked in all patients in the first 24 hours after surgery
At the end of the study statistical analysis will be made parametrically and non-parametrically through the SPSS 2021 program Statistics consultancy will be taken when necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None