Cervical Spine SurgeryPhase 3NCT06721832
The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery
A Phase 3 study testing Erector spina plane block (ESP) and Bupivacain (preoperative) in people with Cervical Spine Surgery and Pain Management, run by Benha University at 1 site in Egypt.
Trial summary
Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Spine Surgery, Pain Management
- What is being tested?
- Erector spina plane block (ESP) and Bupivacain (preoperative)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (ASA )classes I and II
- patients of either sex
- above the age of 18 who will undergo posterior cervical surgery
Who cannot join
- patient's refusal to participate
- any contraindications to peripheral nerve blocks
- history of ischemic heart disease
- patients on opioids for chronic pain
- patients with significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery: a Randomized Controlled Trial
Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016.Cervical erector spinae plane (ESP) block has been described to anesthetize the brachial plexus (BP), however, the mechanism of its clinical effect remains unknown. As the prevertebral fascia encloses the phrenic nerves, BP and erector spinae muscles to form a prevertebral compartment, a local anesthetic injected in the cervical ESP could potentially spread throughout the prevertebral compartment
- Conditions
- Cervical Spine Surgery, Pain Management
- Being tested
- Erector spina plane block (ESP), Bupivacain (preoperative)
- Keywords
- ESP, PAIN, Posterior cervical surgery
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plane block (ESP)Procedure or surgery
The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally.
Bupivacain (preoperative)Drug
The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | patients will receive bilateral in-plane ultrasound guided erector spinea plane block with 30 ml of bupivacaine 0. 25% (15 ml in each side) after induction of general anesthesia Receives: Procedure: Erector spina plane block (ESP); Drug: Bupivacain (preoperative) |
| Group C | Placebo comparator | patients will receive a sham block with 2 ml saline injected subcutaneously (sham block) after induction of general anesthesia Receives: Procedure: Erector spina plane block (ESP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Visual analogue pain score which scales from zero (no pain) to ten (unbearable pain).
Measured: VAS scores at rest and on passive neck movement postoperatively at 24 hours
Secondary outcomes (7)
Postoperative Pain Over Time (Visual analogue scale )
VAS pain scores at rest will be recorded at predefined postoperative intervals to evaluate pain trajectory.
Measured: preoperative ,30 minutes, 2,6,12 and 48 hours postoperatively
Diaphragmatic Excursion
Diaphragmatic excursion will be measured using B-mode and M-mode ultrasonography during quiet breathing. Excursion is defined as the craniocaudal displacement of the diaphragm dome during tidal respiration.
Measured: Baseline (pre-induction), 2 hours after recovery in PACU, and 24 hours postoperatively.
Opioid Consumption
Total intraoperative fentanyl consumption and cumulative morphine consumption during the first 24 postoperative hours. Time to first rescue analgesic request will also be recorded.
Measured: Intraoperative period and first 24 hours postoperatively.
Pulmonary Function
Pulmonary function will be assessed using spirometry to record forced vital capacity (FVC) and forced expiratory volume in one second (FEV₁).
Measured: Baseline (preoperative), 2 hours, and 24 hours postoperatively.
Patient Satisfaction
Patient satisfaction with postoperative analgesia will be evaluated using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied).
Measured: 48 hours postoperatively.
Block-Related Adverse Events
Incidence of block-related adverse events, including desaturation, dyspnea, local anesthetic systemic toxicity, hematoma, or nerve injury.
Measured: 48 hours post-operatively
Length of Hospital Stay
Duration of postoperative hospitalization measured in days.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Abdel Fatah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721832
- Sponsor's protocol ID
- RC 13-10-2024
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-thoracic Erector Spinae Plane Block on Postoperative Pain and Diaphragmatic Function in Posterior Cervical Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06721832
- Acronym / sponsor ID
- RC 13-10-2024
- Conditions
- Cervical Spine Surgery, Pain Management
- Keywords
- ESP, PAIN, Posterior cervical surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 6 Dec 2024 (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.
Posterior cervical spine surgery, often performed on older individuals with significant comorbidities, is one of the most painful surgical operations. Anesthesiologists face a unique challenge in managing pain following these surgeries,Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016.Cervical erector spinae plane (ESP) block has been described to anesthetize the brachial plexus (BP), however, the mechanism of its clinical effect remains unknown. As the prevertebral fascia encloses the phrenic nerves, BP and erector spinae muscles to form a prevertebral compartment, a local anesthetic injected in the cervical ESP could potentially spread throughout the prevertebral compartment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Procedure: Erector spina plane block (ESP), Drug: Bupivacain (preoperative)patients will receive bilateral in-plane ultrasound guided erector spinea plane block with 30 ml of bupivacaine 0. 25% (15 ml in each side) after induction of general anesthesia |
| Group C | Placebo comparator | Procedure: Erector spina plane block (ESP)patients will receive a sham block with 2 ml saline injected subcutaneously (sham block) after induction of general anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (ASA )classes I and II
- patients of either sex
- above the age of 18 who will undergo posterior cervical surgery
Key exclusion criteria (5 listed)
- patient's refusal to participate
- any contraindications to peripheral nerve blocks
- history of ischemic heart disease
- patients on opioids for chronic pain
- patients with significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spina plane block (ESP)The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally. | Procedure or surgery | Group C, Group E |
| Bupivacain (preoperative)The block will be performed in prone position under complete aseptic condition. The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") T1 transverse process will be approached with an 18 G Tuohy's needle in caudal-to-cranial direction. A total of 30 ml of 0.25% bupivacaine was administered deep to erector spinae muscle (ESM) bilaterally. | Drug | Group E |
Primary outcome
Visual analogue scale
Time frame: VAS scores at rest and on passive neck movement postoperatively at 24 hours
Visual analogue pain score which scales from zero (no pain) to ten (unbearable pain).
7 secondary outcomes
Postoperative Pain Over Time (Visual analogue scale )
Time frame: preoperative ,30 minutes, 2,6,12 and 48 hours postoperatively
Diaphragmatic Excursion
Time frame: Baseline (pre-induction), 2 hours after recovery in PACU, and 24 hours postoperatively.
Opioid Consumption
Time frame: Intraoperative period and first 24 hours postoperatively.
Pulmonary Function
Time frame: Baseline (preoperative), 2 hours, and 24 hours postoperatively.
Patient Satisfaction
Time frame: 48 hours postoperatively.
Block-Related Adverse Events
Time frame: 48 hours post-operatively
Length of Hospital Stay
Time frame: 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erector spina plane block (ESP) and Bupivacain (preoperative) in people with Cervical Spine Surgery and Pain Management, run by Benha University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: VAS scores at rest and on passive neck movement postoperatively at 24 hours). 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 1 Sep 2026.