Superficial Cervical Plexus Block for Orthognathic Surgery

NCT04442009 | Withdrawn

• 1 other identifier: Medipol Hospital 15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillofacial Injuries; Maxillofacial Trauma; Maxillofacial Abnormalities; Maxillofacial Dysostosis

Keywords

Orthognathic surgery; Postoperative pain management; Superficial cervical plexus block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain scores (Visual analogue scores-VAS)

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.

Study Arms (2)

Group S = SCPB group

ACTIVE COMPARATOR

US-guided SCPB will be performed at the end of the surgery before extubation, with patients in the supine position by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions using 10% povidone iodine, the high frequency linear probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath and a 22G, 50 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used. Sternocleidomastoid (SCM) muscle will be visualized. The 22 G needle will be inserted between the SCM and the prevertebral fascia by using in plane technique horizontally. The needle tip will be corrected with injecting 2 ml of normal saline. Then a 20 mL dose of 0.25% bupivacaine will be injected here. The same procedure will be performed for the opposite site (totally 40 mL dose of 0.25% bupivacaine).

Other: Group SCPB

Group C = Control group

NO INTERVENTION

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.

Interventions

Group SCPB OTHER

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.

Group S = SCPB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for orthognathic surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related 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.

  PMID: 29969890 BACKGROUND

• 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.

  PMID: 28293792 BACKGROUND

• 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. doi: 10.1093/bja/aeg250.

  PMID: 14570798 BACKGROUND

MeSH Terms

Conditions

Maxillofacial Injuries; Maxillofacial Abnormalities; Maxillofacial Dysostosis

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: There are two models for this study. The first group is superficial cervical plexus block group. The second one is no intervention control group

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: June 22, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)