The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 1, 2025
CompletedStudy Start
First participant enrolled
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 11, 2025
September 1, 2025
7 months
December 19, 2024
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the effect of superficial cervical block application on postoperative opioid use in patients undergoing cervical discectomy surgery via anterior approach.
The amount of tramadol used as rescue analgesic will be compared between the groups.
first 24 hours after the operation
Secondary Outcomes (1)
The aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.
first 24 hours after the operation
Other Outcomes (1)
The aim of this study is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression) of the patients between the groups.
first 24 hours after the operation
Study Arms (2)
control group
NO INTERVENTION1 g intravenous paracetamol and 100 mg intravenous tramadol will be administered 30 minutes before the end of surgery. In addition, 4 mg intravenous ondansetron will be given to prevent postoperative nausea and vomiting.
superficial cervical block
EXPERIMENTALIn addition to routine analgesics applied to the control group, a superficial cervical block will be applied immediately before awakening. The block is performed with the patient in the supine position. A high-frequency (11-12 MHz) linear ultrasound probe is placed at the midpoint of the sternocleidomastoid (SCM) muscle. The ultrasound probe is placed in the transverse plane. During the block, the needle is monitored on the ultrasound image using the in-plane technique. The needle is advanced caudally and directed under the sternocleidomastoid muscle, just above the prevertebral fascia. : The correct position of the needle is confirmed under ultrasound guidance. First, 1-2 ml of saline is injected to confirm the correct location. Then, 20 ml of 0.25% bupivacaine local anesthetic is applied behind the sternocleidomastoid muscle between the muscle and the prevertebral fascia.
Interventions
In anterior cervical discectomy surgeries, superficial cervical block will be used for analgesia.
Eligibility Criteria
You may qualify if:
- Patients scheduled for anterior cervical discectomy surgery
- aged between 18 and 80 years,
- American Society of Anesthesiology (ASA) physical status I-III, scheduled for anterior cervical discectomy surgery will be included.
You may not qualify if:
- history of allergies,
- allergic to local anesthetics,
- pregnant women
- psychiatric or neurological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medipol University
Istanbul, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 23471753BACKGROUNDElvir-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.
PMID: 20847690BACKGROUNDMariappan 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.
PMID: 25869024BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Burak Ömür
Medipol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 19, 2024
First Posted
January 1, 2025
Study Start
January 6, 2025
Primary Completion
August 1, 2025
Study Completion
September 1, 2025
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
only IPD used in the results publication