An interventional study of Group SCPB in Maxillofacial Injuries, Maxillofacial Trauma and Maxillofacial Abnormalities, sponsored by Medipol University. Withdrawn at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Maxillofacial Injuries; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Opioid consumption
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
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
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.
Plan to share: No — We will not plan to share IPD
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