Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442009
Status:
WITHDRAWN
Last Update Posted:
2022-05-04
First Post:
2020-06-19
Brief Title:
Superficial Cervical Plexus Block for Orthognathic Surgery
Sponsor:
Medipol University
Organization:
Medipol University
Study Overview
Official Title:
Ultrasound-guided Superficial Cervical Plexus Block for Pain Management After Orthognathic Surgery
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
US-guided superficial cervical plexus block SCPB may be used for several head and neck surgeries Local anesthetic is injected under the sternocleidomastoid muscle for SCPB It has lower complication rate compared to the deep cervical plexus block Postoperative pain management is important in patients underwent orthognathic surgery Effective pain treatment provides early mobilization and shorter hospital stay
Detailed Description:
Postoperative pain management is very important in patients underwent orthognathic surgery Effective pain control provides early mobilization shorter hospital stay and it increases the satisfaction of the patients Opioid agents may provide effective pain management however opioid agents have undesirable adverse effects such as respiratory depression sedation constipation nausea and vomiting etc Ultrasound US -guided regional anesthesia techniques may be preferred for pain management in patients underwent orthognathic surgery Regional anesthesia techniques may provide effective postoperative pain management as a part of multimodal analgesia regimens US-guided bilateral superficial cervical plexus block SCPB have been performed for several head and neck surgeries and it provides effective pain control The cervical plexus presents between the longus capitis and middle scalene muscles under the prevertebral fascia It is formed by the C2-4 cervical spinal nerves There are the end points of these nerves in the interfascial area under the SCM Thus the superfascial branches of the cervical plexus may be blocked by injecting local anesthetic under the SCM Cervical plexus may be blocked with deep or superficial technique The deep CPB is defined as a paravertebral block The deep branches may be targeted by this method However it has some major disadvantages such as intravascular injection epidural or subarachnoid injection and phrenic nerve palsy due to the deepness of the injection Otherwise SCPB is a superficial method and it has lower complication rate compared to the deep CPB In an anatomical study it has been reported that with SCPB there was spread of dye into the deep cervical fascia The authors emphasized that this mechanism may explain the efficacy of the SCPB Thus with the SCPB both the superficial branches and the deep nerve roots may be blocked Therefore SCPB may provide effective pain management following orthognathic surgery In the literature there are no randomized clinical studies about pain management with US-guided SCPB after orthognathic surgery yet
The aim of this study is to evaluate the efficacy of the US-guided SCPB for postoperative analgesia management after orthognathic surgery The primary aim is to evaluate postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores VAS adverse effects related with opioids allergic reaction nausea vomiting compared to no intervention control group
The aim of this study is to evaluate the efficacy of the US-guided SCPB for postoperative analgesia management after orthognathic surgery The primary aim is to evaluate postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores VAS adverse effects related with opioids allergic reaction nausea vomiting compared to no intervention control group
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