Medipol University
Istanbul, Turkey (Türkiye)
NCT Number: NCT06755736
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
This prospective, randomized controlled trial will be conducted at Medipol Mega University Hospital on patients undergoing anterior cervical discectomy surgery. The study's primary objective is to assess the impact of superficial cervical block on postoperative opioid consumption. Secondary objectives include comparing opioid-related side effects, such as nausea, vomiting, and respiratory depression, and evaluating patients' postoperative Numerical Rating Scale (NRS) pain scores.
Patient Selection:
Eligible participants are aged 18-70 years, with an American Society of Anesthesiologists (ASA) physical status of I-II. Patients with allergies, pregnancy, or neurological/psychiatric conditions will be excluded.
Study Groups:
Participants will be randomly assigned to two groups:
Group 1 (Control): No block will be administered. Group 2 (Intervention): A superficial cervical block will be performed before waking the patient.
Anesthesia Management:
All patients will receive a standard anesthesia protocol, including midazolam, propofol, fentanyl, and rocuronium for induction, followed by maintenance with oxygen-air mix and additional doses of midazolam, fentanyl, and rocuronium. Postoperatively, 1 g paracetamol and 100 mg tramadol will be administered, along with ondansetron to prevent nausea.
Block Technique:
In Group 2, the superficial cervical block will be performed after the surgery is completed but before the patient is awakened. Under sterile conditions and ultrasound guidance, 20 mL of 0.25% bupivacaine will be injected near the superficial branches of the cervical nerves.
Postoperative Evaluation:
Patients' pain levels will be assessed using the Numerical Rating Scale (NRS) at specific intervals (recovery, 3, 6, 12, 18, and 24 hours). A rescue analgesic (1 mg/kg tramadol) will be provided if the NRS score is ≥4. Postoperative opioid consumption, side effects, and complications, including nausea, vomiting, itching, and block-related hematomas, will be recorded.
This study aims to provide valuable insights into the role of superficial cervical block in improving pain management and reducing opioid-related risks in anterior cervical discectomy patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In anterior cervical discectomy surgeries, superficial cervical block will be used for 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.
Time frame: first 24 hours after the operation
The total cumulative dose of tramadol (measured in milligrams) consumed by participants for rescue analgesia.
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.
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.
Medipol University
Other
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.
NCT07398352
Cerebral Perfusion, Interscalene Block
Sanliurfa, Turkey (Türkiye)
View Trial DetailsNCT06860100
Cardiovascular Diseases, Digestive System Diseases
Van, Tuşba, Turkey (Türkiye)
View Trial DetailsNCT07724678
Agnosia, Breast Cancer
Altındağ, Ankara, Turkey (Türkiye)
View Trial DetailsNCT07720999
Dental Caries, Neurologic Manifestations
Cairo, Cairo Governorate, Egypt
View Trial Details