Superficial Cervical Plexus Block for Orthognathic Surgery

Maxillofacial Abnormalities Clinical Trial

Official title:

Ultrasound-guided Superficial Cervical Plexus Block for Pain Management After Orthognathic Surgery.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04442009
• Other study ID #: Medipol Hospital 15
• Status: Withdrawn
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification I-II

• Scheduled for orthognathic surgery under general anesthesia

Exclusion Criteria:

• history of bleeding diathesis,

• receiving anticoagulant treatment,

• known local anesthetics and opioid allergy,

• infection of the skin at the site of the needle puncture,

• pregnancy or lactation,

• patients who do not accept the procedure

Related Conditions & MeSH terms

• Maxillofacial Abnormalities
• Maxillofacial Dysostosis
• Maxillofacial Injuries
• Maxillofacial Trauma

Intervention

Other:
• Group SCPB
In group SCBP, SCBP block will be performed. Patients will be administered dexketoprofen 50 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kim JS, Ko JS, Bang S, Kim H, Lee SY. Cervical plexus block. Korean J Anesthesiol. 2018 Aug;71(4):274-288. doi: 10.4097/kja.d.18.00143. Epub 2018 Jul 4. — View Citation

Pandit JJ, Dutta D, Morris JF. Spread of injectate with superficial cervical plexus block in humans: an anatomical study. Br J Anaesth. 2003 Nov;91(5):733-5. — View Citation

Raschke GF, Meissner W, Peisker A, Djedovic G, Rieger U, Guentsch A, Dammeier MG, Schultze-Mosgau S. Bilateral sagittal split osteotomy-parameters and correlations of postoperative pain management. Clin Oral Investig. 2018 Jan;22(1):181-187. doi: 10.1007/s00784-017-2097-z. Epub 2017 Mar 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	The primary aim is to compare postoperative opioid consumption	Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours
Secondary	Pain scores (Visual analogue scores-VAS)	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.