NCT06755736

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

December 19, 2024

Last Update Submit

September 10, 2025

Conditions

Keywords

superficial cervical blockanterior cervical discectomyregional anesthesia

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 INTERVENTION

1 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

EXPERIMENTAL

In 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.

Drug: superficial cervical plexus block

Interventions

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

superficial cervical block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 23471753BACKGROUND
  • Elvir-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: 20847690BACKGROUND
  • Mariappan 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

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Burak Ömür

    Medipol University

    STUDY DIRECTOR

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

Locations