Skip to main content
OpenTrials
Completed

NCT Number: NCT06755736

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superficial cervical plexus block

Drug

In anterior cervical discectomy surgeries, superficial cervical block will be used for analgesia.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total Cumulative Tramadol Consumption

    Time frame: first 24 hours after the operation

    The total cumulative dose of tramadol (measured in milligrams) consumed by participants for rescue analgesia.

Other outcomes

  1. Postoperative Pain Scores (Static and Dynamic)

    Time frame: first 24 hours after the operation

    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.

  2. Incidence of Adverse Events

    Time frame: first 24 hours after the operation

    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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 1, 2025
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.