Pain, Postoperative Clinical Trial
Official title:
Efficacy of Adding Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery: Randomized Controlled Study
Verified date | April 2023 |
Source | National Cancer Institute, Egypt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The cervical plexus block (CPB) is one such block used to provide effective anesthesia and analgesia for surgery in the head and neck region. The cervical fascia was first described as a very strong and resisting structure, consisting of two layers, superficial and deep. But more recently classified the cervical fascia as superficial/subcutaneous and deep. The deep cervical fascia is further divided into three layers: (a) the superficial layer, which was also called the investing fascia but is now referred to as the masticator fascia, submandibular fascia or sternocleidomastoid (SCM)-trapezius fascia, (b) the middle layer, which is suggested as to be named as strap muscle fascia or visceral fascia; and (c) the deep layer or the 'prevertebral fascia'. Intermediate cervical plexus block (CPB) has been found to be very effective in procedures of neck such as thyroid surgeries and carotid endarterectomy. The duration of analgesia following the nerve blocks is a matter of concern as most of the blocks last for only a few hours. Interestingly, resurgence of the use of α2-agonists in combination with local anesthetics has dramatically improved the duration of action of these blocks. Dexmedetomidine is a potent α2 agonist and is now emerging as an adjuvant to regional anesthesia and analgesia. Little evidence is available supporting the usefulness of dexmedetomidine in bilateral intermediate CPB. Therefore, the current study will be conducted to compare the duration and effectiveness of post-thyroidectomy analgesia of bilateral intermediate CPB using 20 ml bupivacaine 0.25% (Group A) or 20 ml of bupivacaine 0.25% with 1 μg/kg dexmedetomidine (Group B).
Status | Completed |
Enrollment | 60 |
Est. completion date | November 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Physical status American society Anesthesiologists ASA II and III. - Age = 18 and = 60 Years. - Patient undergoing thyroidectomy for cancer surgery. Exclusion Criteria: - Patient refusal. - Known sensitivity or contraindication to local anesthetics or dexmedetomidine. - History of psychological disorders. - Retro-sternal goiter and altered anatomical landmarks. - Localized infection at the site of block. - Coagulopathy with international normalized ratio (INR) = 1.6: hereditary (e.g., hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g., impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs). |
Country | Name | City | State |
---|---|---|---|
Egypt | National Cancer Institue | Cairo | Fom El Khalig |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute, Egypt |
Egypt,
Andersen JH, Grevstad U, Siegel H, Dahl JB, Mathiesen O, Jaeger P. Does Dexmedetomidine Have a Perineural Mechanism of Action When Used as an Adjuvant to Ropivacaine?: A Paired, Blinded, Randomized Trial in Healthy Volunteers. Anesthesiology. 2017 Jan;126(1):66-73. doi: 10.1097/ALN.0000000000001429. — View Citation
Egan RJ, Hopkins JC, Beamish AJ, Shah R, Edwards AG, Morgan JD. Randomized clinical trial of intraoperative superficial cervical plexus block versus incisional local anaesthesia in thyroid and parathyroid surgery. Br J Surg. 2013 Dec;100(13):1732-8. doi: 10.1002/bjs.9292. — View Citation
Guidera AK, Dawes PJ, Fong A, Stringer MD. Head and neck fascia and compartments: no space for spaces. Head Neck. 2014 Jul;36(7):1058-68. doi: 10.1002/hed.23442. Epub 2014 Jan 29. — View Citation
Kaygusuz K, Kol IO, Duger C, Gursoy S, Ozturk H, Kayacan U, Aydin R, Mimaroglu C. Effects of adding dexmedetomidine to levobupivacaine in axillary brachial plexus block. Curr Ther Res Clin Exp. 2012 Jun;73(3):103-11. doi: 10.1016/j.curtheres.2012.03.001. — View Citation
Kim, J.-S. and H.Y. Kim, Cervical plexus block. Surgical Anatomy of the Cervical Plexus and its Branches, 2022: p. 189-202.
Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7. — View Citation
Syal K, Chandel A, Goyal A, Sharma A. Comparison of ultrasound-guided intermediate vs subcutaneous cervical plexus block for postoperative analgesia in patients undergoing total thyroidectomy: A randomised double-blind trial. Indian J Anaesth. 2020 Jan;64(1):37-42. doi: 10.4103/ija.IJA_483_19. Epub 2020 Jan 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | first rescue analgesia | First time (minutes) opioids requested postoperative when pain score is >3 . | the first 24 hours of postoperative period | |
Secondary | Total intraoperative fentanyl consumption. | the doses of fentanyl will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels. | throughout the duration of the surgery | |
Secondary | postoperative opioids consumption. | Total patient's morphine requirements within 24 hours postoperative. | 24 hours postoperative | |
Secondary | Post-operative pain scores. | Post-operative pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals | immediately postoperative (0 hours ), 2, 4, 6, 12 and 24 hours postoperative | |
Secondary | Any complications will be recorded. | Any complications such as failed block, hypotension, unintentional intravascular injection of LA and local anesthetic toxicity will be recorded. | throughout the duration of the surgery and 24 hours postoperative |
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