Clinical Trials Directory

Trials / Completed

CompletedNCT06755736

The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Medipol University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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. 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 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 18-80 years, with an American Society of Anesthesiologists (ASA) physical status of I-III. 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.

Conditions

Interventions

TypeNameDescription
DRUGsuperficial cervical plexus blockIn anterior cervical discectomy surgeries, superficial cervical block will be used for analgesia.

Timeline

Start date
2025-01-06
Primary completion
2025-08-01
Completion
2025-09-01
First posted
2025-01-01
Last updated
2025-09-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06755736. Inclusion in this directory is not an endorsement.