Acute PainNCT07694180
Postoperative Outcomes of Regional Blocks in Cervical Disc Surgery
An observational study of Acute Pain and Servical Disc Herniation, run by Samsun University.
Trial summary
The aim of this study is to evaluate the postoperative analgesic efficacy of the Serratus Posterior Superior Intercostal Plane Block (SPSIP block) in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery and to compare the outcomes with those of patients who do not receive regional anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain, Servical Disc Herniation
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 2 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18-70 years with ASA physical status I-III who are scheduled to undergo elective anterior cervical discectomy and fusion (ACDF) surgery under general anesthesia at Samsun City Hospital. Eligible patients who provide written informed consent and meet the study inclusion criteria will be enrolled consecutively during the study period
Who may be able to join
- Patients aged between 18 and 70 years.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective anterior cervical discectomy and fusion (ACDF) surgery under general anesthesia.
- Patients who provide written informed consent and agree to participate in the study.
Who cannot join
- Patients with a history of bleeding diathesis or those receiving anticoagulant therapy.
- Patients with a known allergy or hypersensitivity to local anesthetics or opioid medications.
- Patients with infection at the planned block site.
- Patients with a history of previous cervical spine surgery.
- Patients with a history of gabapentinoid or corticosteroid use within the last 3 weeks.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Betül Çiftçi Kurt contact
About this study
Official title: Postoperative Outcomes of Regional Blocks Performed in Cervical Disc Surgery: A Prospective Observational Study
The aim of this study is to evaluate the postoperative analgesic efficacy of the Serratus Posterior Superior Intercostal Plane Block (SPSIP block) in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery and to compare the outcomes with those of patients who do not receive regional anesthesia.
Read the detailed description
Cervical disc disorders may lead to various signs and symptoms, including neck pain, radicular pain in the upper extremities, sensory disturbances, motor weakness, and functional impairment. Anterior cervical discectomy and fusion (ACDF) is a widely accepted surgical procedure for the treatment of cervical disc herniation and other degenerative cervical spine disorders. However, postoperative pain remains a significant concern and may adversely affect recovery and patient comfort.
A multimodal analgesic approach is commonly preferred for postoperative pain management following cervical spine surgery. The incorporation of regional anesthesia techniques may reduce opioid consumption and opioid-related adverse effects while facilitating earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing ACDF surgery, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) has emerged as a promising regional anesthesia technique for postoperative pain control. This study aims to evaluate the postoperative analgesic efficacy of SPSIPB and compare postoperative outcomes between patients receiving SPSIPB and those managed without regional anesthesia.
- Conditions
- Acute Pain, Servical Disc Herniation
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group-SPSİPB | The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be administered under ultrasound guidance 30 minutes before the induction of anesthesia for anterior cervical discectomy and fusion (ACDF) surgery. | |
| Group-Control | Patients in the control group will not receive any regional anesthesia technique before surgery and will undergo anterior cervical discectomy and fusion (ACDF) surgery under standard general anesthesia. Postoperative pain management will be provided according to the institution's routine multimodal analgesia protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Measured: 24 hours
1. Opioid consumption
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Measured: 24 hours
Secondary outcomes (3)
2. Perioperative pain intensity
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain').
Measured: 24 hours
Quality of recovery 15 scale
Postoperative Quality of Recovery 15 in Turkish scale. The QoR-15 (Quality of Recovery-15) questionnaire is a simple and practical tool used to assess postoperative recovery. It consists of 15 items, each scored on a numeric scale from 0 to 10, resulting in a total score ranging from 0 to 150. Based on the total score, postoperative recovery is categorized as follows: 136-150: Excellent recovery 122-135: Good recovery 90-121: Moderate recovery 0-89: Poor recovery
Measured: 24 hours after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV): During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start22 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694180
- Sponsor's protocol ID
- GOKAEK 2026/11/21
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes of Regional Blocks Performed in Cervical Disc Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07694180
- Acronym / sponsor ID
- GOKAEK 2026/11/21
- Conditions
- Acute Pain, Servical Disc Herniation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the postoperative analgesic efficacy of the Serratus Posterior Superior Intercostal Plane Block (SPSIP block) in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery and to compare the outcomes with those of patients who do not receive regional anesthesia.
Detailed description
Cervical disc disorders may lead to various signs and symptoms, including neck pain, radicular pain in the upper extremities, sensory disturbances, motor weakness, and functional impairment. Anterior cervical discectomy and fusion (ACDF) is a widely accepted surgical procedure for the treatment of cervical disc herniation and other degenerative cervical spine disorders. However, postoperative pain remains a significant concern and may adversely affect recovery and patient comfort.
A multimodal analgesic approach is commonly preferred for postoperative pain management following cervical spine surgery. The incorporation of regional anesthesia techniques may reduce opioid consumption and opioid-related adverse effects while facilitating earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing ACDF surgery, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) has emerged as a promising regional anesthesia technique for postoperative pain control. This study aims to evaluate the postoperative analgesic efficacy of SPSIPB and compare postoperative outcomes between patients receiving SPSIPB and those managed without regional anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-SPSİPB | – | –The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be administered under ultrasound guidance 30 minutes before the induction of anesthesia for anterior cervical discectomy and fusion (ACDF) surgery. |
| Group-Control | – | –Patients in the control group will not receive any regional anesthesia technique before surgery and will undergo anterior cervical discectomy and fusion (ACDF) surgery under standard general anesthesia. Postoperative pain management will be provided according to the institution's routine multimodal analgesia protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18-70 years with ASA physical status I-III who are scheduled to undergo elective anterior cervical discectomy and fusion (ACDF) surgery under general anesthesia at Samsun City Hospital. Eligible patients who provide written informed consent and meet the study inclusion criteria will be enrolled consecutively during the study period
Key inclusion criteria (4 listed)
- Patients aged between 18 and 70 years.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Patients scheduled for elective anterior cervical discectomy and fusion (ACDF) surgery under general anesthesia.
- Patients who provide written informed consent and agree to participate in the study.
Key exclusion criteria (5 listed)
- Patients with a history of bleeding diathesis or those receiving anticoagulant therapy.
- Patients with a known allergy or hypersensitivity to local anesthetics or opioid medications.
- Patients with infection at the planned block site.
- Patients with a history of previous cervical spine surgery.
- Patients with a history of gabapentinoid or corticosteroid use within the last 3 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid consumption
Time frame: 24 hours
1. Opioid consumption
Time frame: 24 hours
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
3 secondary outcomes
2. Perioperative pain intensity
Time frame: 24 hours
Quality of recovery 15 scale
Time frame: 24 hours after surgery
Postoperative nausea and vomiting
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Betül Çiftçi Kurt contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Servical Disc Herniation, run by Samsun University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HALE KEFELİ ÇELİK (5057242409, ck_hale@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.