NCT07694180

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jun 2026Jan 2027

Study Start

First participant enrolled

June 22, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Opioid consumption

    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.

    24 hours

Secondary Outcomes (3)

  • 2. Perioperative pain intensity

    24 hours

  • Quality of recovery 15 scale

    24 hours after surgery

  • Postoperative nausea and vomiting

    24 hours

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

HALE KEFELİ ÇELİK

CONTACT

Betül Çiftçi Kurt

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 2, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07