Superficial Cervical BlockNCT06755736
The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery
A study testing superficial cervical plexus block in people with Superficial Cervical Block and Postoperative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of superficial cervical block on postoperative opioid consumption in patients undergoing anterior cervical discectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Superficial Cervical Block, Postoperative Pain
- What is being tested?
- superficial cervical plexus block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Superficial Cervical Block, Postoperative Pain
- Being tested
- superficial cervical plexus block
- Keywords
- superficial cervical block, anterior cervical discectomy, regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial cervical plexus blockDrug
In anterior cervical discectomy surgeries, superficial cervical block will be used for analgesia.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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. |
| superficial cervical block | Experimental | 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. Receives: Drug: superficial cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Requiring Postoperative Rescue Analgesia
The number of participants requiring tramadol as a rescue analgesic during the first 24 hours after surgery.
Measured: first 24 hours after the operation
Secondary outcomes (1)
Total Cumulative Tramadol Consumption
The total cumulative dose of tramadol (measured in milligrams) consumed by participants for rescue analgesia.
Measured: first 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start6 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Superficial Cervical BlockStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
- Investigators
- Burak Ömür, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755736
- Sponsor's protocol ID
- E-10840098-202.3.02-7384
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Publications
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.
PubMed 23471753Elvir-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.
PubMed 20847690Mariappan 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.
PubMed 25869024
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery
- ClinicalTrials.gov ID
- NCT06755736
- Acronym / sponsor ID
- E-10840098-202.3.02-7384
- Conditions
- Superficial Cervical Block, Postoperative Pain
- Keywords
- superficial cervical block, anterior cervical discectomy, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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. |
| superficial cervical block | Experimental | Drug: superficial cervical plexus blockIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superficial cervical plexus blockIn anterior cervical discectomy surgeries, superficial cervical block will be used for analgesia. | Drug | superficial cervical block |
Primary outcome
Incidence of Requiring Postoperative Rescue Analgesia
Time frame: first 24 hours after the operation
The number of participants requiring tramadol as a rescue analgesic during the first 24 hours after surgery.
1 secondary outcome
Total Cumulative Tramadol Consumption
Time frame: first 24 hours after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 23471753Gornall 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.
- Background: PubMed 20847690Elvir-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.
- Background: PubMed 25869024Mariappan 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.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Superficial Cervical Block
Recruiting
Comparative Study of Ultrasound Guided Superficial vs Intermediate Cervical Plexus Block for Perioperative Analgesia in Thyroid Surgeries.
Thyroid Surgeries
Not yet recruitingObservational study
Cerebral Oximetry During Awake Carotid Endarterectomy
Carotid Stenosis, Carotid Artery Diseases
Enrolling by invitation
Comparison of Two Drugs Bupivacaine and Ropivacaine for Postoperative Analgesia in Bilateral Superficial Cervical Plexus Block After Thyroidectomy
Postoperative Pain
Active, not recruiting
ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery
Post Operative Pain, Nausea and Vomiting, Postoperative
Active, not recruitingPhase 4
Analgesic Effect of Superficial Cervical Plexus Block in Postoperative Neck Surgeries
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Ömür study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superficial cervical plexus block in people with Superficial Cervical Block and Postoperative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Requiring Postoperative Rescue Analgesia (time frame: first 24 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06755736, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.