The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery
This randomized controlled trial aims to evaluate the effect of superficial cervical block on postoperative opioid consumption in patients undergoing anterior cervical discectomy surgery. Postoperative pain significantly impacts recovery and patient comfort in this type of surgery, where symptoms such as swallowing difficulties, occipito-cervical pain, and positional discomfort are common. While opioids are effective for pain control, their side effects, such as nausea, vomiting, and respiratory depression, may lead to complications, especially in cervical surgeries with potential airway risks.
Superficial cervical block is a simple and safe regional anesthesia technique proven effective in managing pain after thyroid and carotid surgeries. However, its potential benefits in anterior cervical discectomy surgeries have not been extensively studied.
Our hypothesis is that superficial cervical block can reduce postoperative opioid use and provide effective pain management for these patients. Additionally, investigators aim to compare opioid-related side effects and postoperative pain scores between groups with and without the block.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized, double-blind, controlled trial is conducted at Medipol Mega University Hospital in patients undergoing microscopic anterior cervical discectomy and fusion (ACDF). The primary objective is to assess the effect of a superficial cervical plexus block on the incidence of requiring postoperative rescue analgesia. Secondary objectives are total cumulative tramadol consumption, the incidence of opioid-related adverse events (nausea, vomiting, pruritus) and postoperative Numerical Rating Scale (NRS) pain scores at rest and on movement.
Patient selection:
Eligible participants are aged 18-70 years with an American Society of Anesthesiologists (ASA) physical status of I-II, scheduled for unilateral single- or two-level microscopic ACDF under general anaesthesia. Exclusion criteria are bleeding diathesis, anticoagulant therapy, known local anaesthetic or opioid allergy, a history of chronic pain, infection of the skin at the puncture site, and refusal to participate.
Study groups:
Participants are randomly assigned to two groups. Group 1 (control) receives no regional block. Group 2 (intervention) receives a right-sided superficial cervical plexus block at the end of surgery, before awakening.
Anaesthesia management:
General anaesthesia is induced with intravenous propofol (2-3 mg/kg), fentanyl (1.5 mcg/kg) and rocuronium (0.6 mg/kg), and maintained with a remifentanil infusion (0.05-2 mcg/kg/min) and desflurane in an air-oxygen mixture. A remifentanil bolus (0.5 mcg/kg) is given if heart rate or mean arterial pressure rises more than 20% above the pre-induction baseline. All patients receive intravenous ondansetron 4 mg, paracetamol 1 g and tramadol 100 mg thirty minutes before surgery. Surgery is performed by the same team through a right-sided anterior cervical approach with a 3-4 cm transverse skin incision; no local anaesthetic or adrenaline infiltration is performed at the incision site in either group. Discectomy, neural decompression and interbody cage insertion are performed under the operating microscope.
Block technique:
Under ultrasound guidance, 20 mL of 0.25% bupivacaine is injected superficial to the investing layer of the deep cervical fascia at the posterior border of the sternocleidomastoid muscle.
Postoperative evaluation:
NRS pain scores at rest and on movement are recorded at 1, 3, 6, 12, 18 and 24 hours after surgery. Rescue analgesia (1 mg/kg intravenous tramadol) is given if the NRS score is 4 or above. Postoperative opioid consumption, adverse events (nausea, vomiting, pruritus) and block-related complications are recorded over the first 24 postoperative hours.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 70 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for unilateral single- or two-level microscopic anterior cervical discectomy and fusion (ACDF) under general anaesthesia
Exclusion Criteria:
- History of bleeding diathesis,
- Receiving anticoagulant treatment,
- Known local anesthetics and opioid allergy,
- History of chronic pain
- Infection of the skin at the site of the needle puncture,
- Patients who do not accept the procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: control group
1 g intravenous paracetamol, 100 mg intravenous tramadol and 4 mg intravenous ondansetron are administered 30 minutes before surgery.
Postoperatively, 1 g intravenous paracetamol is given every 8 hours.
Rescue analgesia is 1 mg/kg intravenous tramadol when the Numerical Rating Scale score is 4 or above.
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Experimental: superficial cervical block
In addition to the routine analgesia given to the control group, a right-sided superficial cervical plexus block is performed at the end of surgery, immediately before awakening, with the patient in the supine position.
A high-frequency linear ultrasound probe is placed transversely on the right side of the neck at the level of the fourth cervical vertebra to identify the sternocleidomastoid (SCM) muscle, the investing layer of the deep cervical fascia, the internal jugular vein and the carotid artery.
A 50-mm block needle is advanced in plane at a shallow angle, from lateral to medial, towards the posterior border of the SCM.
The needle tip is positioned superficial to the investing layer of the deep cervical fascia; neither the SCM nor the prevertebral fascia is traversed.
After confirming correct placement with 1-2 mL of saline, 20 mL of 0.25% bupivacaine is injected in this plane.
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In anterior cervical discectomy surgeries, superficial cervical block will be used for analgesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Requiring Postoperative Rescue Analgesia
Time Frame: first 24 hours after the operation
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The number of participants requiring tramadol as a rescue analgesic during the first 24 hours after surgery.
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first 24 hours after the operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Cumulative Tramadol Consumption
Time Frame: first 24 hours after the operation
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The total cumulative dose of tramadol (measured in milligrams) consumed by participants for rescue analgesia.
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first 24 hours after the operation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Pain Scores (Static and Dynamic)
Time Frame: first 24 hours after the operation
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Postoperative pain severity assessed using the Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain.
Both static (at rest) and dynamic (during movement/coughing) scores are evaluated.
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first 24 hours after the operation
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Incidence of Adverse Events
Time Frame: first 24 hours after the operation
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The rate and number of participants experiencing any postoperative adverse events (e.g., postoperative nausea and vomiting, pruritus, or respiratory depression) within the first 24-hour period.
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first 24 hours after the operation
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Burak Ömür, Medipol University
Publications and helpful links
General Publications
- Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010 Dec;23(6):697-703. doi: 10.1097/ACO.0b013e32833fad0a.
- Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
- Mariappan R, Mehta J, Massicotte E, Nagappa M, Manninen P, Venkatraghavan L. Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):883-90. doi: 10.1007/s12630-015-0382-3. Epub 2015 Apr 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-7384
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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