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

NCT ID: NCT06755736

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2025-09-01

Brief Summary

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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

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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

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Superficial Cervical Block Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

superficial cervical block

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.

Group Type EXPERIMENTAL

superficial cervical plexus block

Intervention Type DRUG

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

Interventions

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superficial cervical plexus block

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* history of allergies,
* allergic to local anesthetics,
* pregnant women
* psychiatric or neurological disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Burak Omur

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burak Ömür

Role: STUDY_DIRECTOR

Medipol University

Locations

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Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23471753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20847690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25869024 (View on PubMed)

Other Identifiers

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E-10840098-202.3.02-7384

Identifier Type: -

Identifier Source: org_study_id

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