Maxillofacial Abnormalities, Maxillofacial Dysostosis, Maxillofacial Injuries, Maxillofacial Trauma
Conditions
Keywords
Orthognathic surgery, Postoperative pain management, Superficial cervical plexus block
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.
Interventions
OTHERGroup 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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The anesthesiologist who performs postoperative pain evaluation will not know the group.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours | The primary aim is to compare postoperative opioid consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (Visual analogue scores-VAS) | Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours. | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed