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Superficial Cervical Plexus Block for Orthognathic Surgery

Primary Purpose

Maxillofacial Injuries, Maxillofacial Trauma, Maxillofacial Abnormalities

Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group SCPB
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillofacial Injuries focused on measuring Orthognathic surgery, Postoperative pain management, Superficial cervical plexus block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group S = SCPB group

Group C = Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Opioid consumption
The primary aim is to compare postoperative opioid consumption

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2020
Last Updated
April 28, 2022
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04442009
Brief Title
Superficial Cervical Plexus Block for Orthognathic Surgery
Official Title
Ultrasound-guided Superficial Cervical Plexus Block for Pain Management After Orthognathic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participants
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Injuries, Maxillofacial Trauma, Maxillofacial Abnormalities, Maxillofacial Dysostosis
Keywords
Orthognathic surgery, Postoperative pain management, Superficial cervical plexus block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. The first group is superficial cervical plexus block group. The second one is no intervention control group
Masking
ParticipantOutcomes Assessor
Masking Description
The anesthesiologist who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group S = SCPB group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group C = Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Group SCPB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
The primary aim is to compare postoperative opioid consumption
Time Frame
Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours
Secondary Outcome Measure Information:
Title
Pain scores (Visual analogue scores-VAS)
Description
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
Time Frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not plan to share IPD
Citations:
PubMed Identifier
29969890
Citation
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.
Results Reference
background
PubMed Identifier
28293792
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.
Results Reference
background
PubMed Identifier
14570798
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. doi: 10.1093/bja/aeg250.
Results Reference
background

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Superficial Cervical Plexus Block for Orthognathic Surgery

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