Anesthesia, LocalPhase 3ESPB/ICPBNCT06867510
Preoperative Block for Anterior Cervical Spine Surgery
A Phase 3 study testing Block for Anterior Cervical Spine Surgery in people with Anesthesia, Local, run by Tanta University at 1 site in Egypt.
Trial summary
The purpose of this clinical trial study is to compare the analgesic effects of ultrasound-guided intermediate cervical plexus block Versus cervical erector spinae block in patients undergoing anterior cervical spine surgery. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Block for Anterior Cervical Spine Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Aug 2026
- Phase
- Phase 3
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sex
- Age: between 21 and 60 years
- Physical status: belongs to American Society of Anesthesiologists (ASA) I, II
- Body mass index (BMI): from 25 to 30 kg/m2
- Type of surgery: elective anterior cervical spine surgery under general anesthesia
Who cannot join
- Refusal of participation.
- local infection at the puncture site.
- Mental or physical disability.
- History of allergy to study drugs (bupivacaine, fentanyl).
- Hematological disorders including coagulation abnormalities.
- Severe hepatic or kidney impairment.
- Chronic pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University Teaching Hospital
Tanta, Qism Awwal Tanta, 31111
+20403339058, edu_hospital@unv.tanta.edu.eg
About this study
Official title: Preoperative Ultrasound-Guided Intermediate Cervical Plexus Block Versus Preoperative Cervical Erector Spinae Plane Block for Anterior Cervical Spine Surgery: A Randomized Controlled Study
The purpose of this clinical trial study is to compare the analgesic effects of ultrasound-guided intermediate cervical plexus block Versus cervical erector spinae block in patients undergoing anterior cervical spine surgery.
- The main questions it aims to answer are:
- The primary outcome will be recording postoperative pain intensity using Numerical Rating Scale (NRS).
- The secondary outcomes will be measuring the performance time, onset of the sensory block, intraoperative fentanyl consumption, time to the first call for rescue analgesia (nalbuphine), postoperative total nalbuphine consumption, and postoperative complications such as nausea, vomiting, hypotension, and bradycardia.
- We will compare two blocks to a placebo.
- Participants will:
- undergo ultrasound-guided intermediate cervical plexus block or cervical erector spinae block or a placebo
- Be assessed for pain after 2 h, 4 h, 6 h, 12 h, and 24 h postoperatively
Read the detailed description
Anterior cervical spine surgery is a common procedure for treating disc herniation, spinal cord vascular diseases, cervical spondylosis, and tumors. Cervical spine surgery is one of the most painful surgical operations, ranked among the 6 most painful out of 179 assessed surgical procedures, underscoring the challenges in pain management for this patients. Many patients requiring spine surgery are also overweight, have substance use disorders and other comorbidities related to aging.
Surgeons have been able to effectively treat patients with various cervical spine conditions by using specialized retractors, natural muscle planes, and paying careful attention to surrounding structures. However, despite the high success rates associated with these surgeries, patients often experience postoperative pain between the shoulder blades and in the neck.
Improper perioperative pain management after anterior cervical spine surgery can impact a patient's recovery, overall health, ability to swallow, may lead to nausea, vomiting, and chronic pain. Thus, effective pain management techniques are crucial to enhance postoperative care for these patients.
A regional analgesia block is a technique used to suppress nerve transmission and alleviate or prevent pain. It is commonly used in combination with general anesthesia or as the sole anesthetic technique, particularly in plastic, orthopedic and vascular surgeries to reduce the amount of anesthetic and analgesic agents needed, minimize systemic side effects, improve recovery, provide better postoperative pain relief, and shorten hospital stays.
The cervical plexus is made up of the ventral rami of the C1-C4 spinal nerves. The cervical plexus consists of motor (phrenic nerve, direct muscle branches) and terminal sensory branches (C2-C4): the supraclavicular nerves, the lesser occipital nerve, greater auricular nerve, and transverse cervical nerve. The latter is formed in the compartment between the prevertebral and superficial layer of the cervical fascia, deep to the sternocleidomastoid. Before 2004, any cervical plexus blocks that were performed superficially to the prevertebral fascia were termed superficial cervical plexus blocks. However, Telford and Stoneham suggested the term intermediate cervical plexus block to distinguish between the superficial block (subcutaneous or subplatysmal) and the block in the interfascial compartment. Intermediate cervical plexus block is a safe, popular, easy, and effective technique for regional analgesia of cervical region. The use of ultrasound guidance reduces the risk of complications, allows for real-time visualization of anatomical structures, and helps guide needle placement.
Bilateral cervical erector spinae block using ultrasound has recently been studied for shoulder surgery. Since the brachial plexus, phrenic nerves, cervical nerve roots, and deep cervical muscles are enclosed in the prevertebral fascia, injecting a local anesthetic near the cervical transverse process can spread to nearby structures within the prevertebral compartment. In a cadaver study, it was found that injecting a 20 mL dye solution into the transverse process of C6 or C7 resulted in staining of the C5-T1 nerve roots.
With the increasing number of nerve block techniques available, anesthesiologists may have difficulty determining the most appropriate technique to achieve optimal recovery after anterior cervical spine surgery. Therefore, this study will conducted to compare the efficacy of ultrasound-guided intermediate cervical plexus block and cervical erector spinae block in patients undergoing anterior cervical spine surgery.
- Conditions
- Anesthesia, Local
- Being tested
- Block for Anterior Cervical Spine Surgery, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Regional anesthesia in cervical spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block for Anterior Cervical Spine SurgeryProcedure or surgery
The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side
Saline (NaCl 0,9 %) (placebo)Drug
Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Intermediate cervical plexus block | Active comparator | The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side. Receives: Procedure: Block for Anterior Cervical Spine Surgery |
| Cervical Erector spinae block | Active comparator | The patient will be positioned laterally, with a pillow under their head. Transverse ultrasound scanning of the lower cervical area will be done. Starting from the supraclavicular brachial plexus, the transducer will be slid in a cephalic direction to show the transverse process of the C7 vertebra. Then, it will be moved further cephalic to display the transverse process of C6, along with its characteristic anterior and posterior tubercles. The transducer will be then slid posteriorly to show the posterior tubercle of C6, along with the posterior neck muscles above it (trapezius, levator scapula, and erector spinae). After prepping and draping the patient using aseptic technique, the needle will be inserted (in plane technique from posterior) until it will reach the posterior tubercle of C6. Then, a total volume of 15 ml of bupivacaine 0.25% will be injected bilaterally. The same steps will be repeated on the opposite side. Receives: Procedure: Block for Anterior Cervical Spine Surgery |
| Control group | Placebo comparator | Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postoperative pain intensity using Numerical Rating Scale
Numeric Rating Scale ( NRS) score, a commonly used 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme ( pain as bad as you can imagine or worst pain imaginable). The patient will be instructed to mark along the line to represent the intensity of pain currently being experienced.
Measured: (Day 1) 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperative
Secondary outcomes (3)
Change in the time of performance of the technique in minutes.
Time of performance of the technique: the time from probe insertion until the visualization of local anesthetic spread in minutes.
Measured: Perioperative/Periprocedural
Change in the time to the first call for analgesia (nalbuphine) in hours.
The time to the first call for rescue analgesia (nalbuphine), which is the time between the end of surgery and the first report of postoperative pain, will be recorded in hours.
Measured: Perioperative/Periprocedural
The total measure of nalbuphine given to each patient during the first 24 hours of the postoperative period
The total amount of nalbuphine in milligrams given to each patient during the first 24 hours of the postoperative period will be recorded.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Model description
- All blocks will be conducted under sterile conditions in the operating room with sedation "midazolam 0.03-0.05 mg/kg as needed" 30 minutes before induction of general anesthesia. a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd Elfatah khodair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867510
- Sponsor's protocol ID
- Block in Spine Surgery
- Acronym
- ESPB/ICPB
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamel AAF, Fahmy AM, Fathi HM, Elmesallamy WAEA, Khalifa OYA. Regional analgesia using ultrasound-guided intermediate cervical plexus block versus cervical erector spinae block for anterior cervical spine surgery: a randomized trial. BMC Anesthesiol. 2024 Apr 22;24(1):153. doi: 10.1186/s12871-024-02533-6.
PubMed 38649826Abdelhaleem NF, Youssef EM, Hegab AS. Analgesic efficacy of inter-semispinal fascial plane block in Patients undergoing Cervical Spine Surgery through Posterior Approach: a randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101213. doi: 10.1016/j.accpm.2023.101213. Epub 2023 Mar 7.
PubMed 36894055
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound-Guided Intermediate Cervical Plexus Block Versus Preoperative Cervical Erector Spinae Plane Block for Anterior Cervical Spine Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06867510
- Acronym / sponsor ID
- ESPB/ICPB / Block in Spine Surgery
- Conditions
- Anesthesia, Local
- Keywords
- Regional anesthesia in cervical spine surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Mar 2025 (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 purpose of this clinical trial study is to compare the analgesic effects of ultrasound-guided intermediate cervical plexus block Versus cervical erector spinae block in patients undergoing anterior cervical spine surgery.
- The main questions it aims to answer are:
- The primary outcome will be recording postoperative pain intensity using Numerical Rating Scale (NRS).
- The secondary outcomes will be measuring the performance time, onset of the sensory block, intraoperative fentanyl consumption, time to the first call for rescue analgesia (nalbuphine), postoperative total nalbuphine consumption, and postoperative complications such as nausea, vomiting, hypotension, and bradycardia.
- We will compare two blocks to a placebo.
- Participants will:
- undergo ultrasound-guided intermediate cervical plexus block or cervical erector spinae block or a placebo
- Be assessed for pain after 2 h, 4 h, 6 h, 12 h, and 24 h postoperatively
Detailed description
Anterior cervical spine surgery is a common procedure for treating disc herniation, spinal cord vascular diseases, cervical spondylosis, and tumors. Cervical spine surgery is one of the most painful surgical operations, ranked among the 6 most painful out of 179 assessed surgical procedures, underscoring the challenges in pain management for this patients. Many patients requiring spine surgery are also overweight, have substance use disorders and other comorbidities related to aging.
Surgeons have been able to effectively treat patients with various cervical spine conditions by using specialized retractors, natural muscle planes, and paying careful attention to surrounding structures. However, despite the high success rates associated with these surgeries, patients often experience postoperative pain between the shoulder blades and in the neck.
Improper perioperative pain management after anterior cervical spine surgery can impact a patient's recovery, overall health, ability to swallow, may lead to nausea, vomiting, and chronic pain. Thus, effective pain management techniques are crucial to enhance postoperative care for these patients.
A regional analgesia block is a technique used to suppress nerve transmission and alleviate or prevent pain. It is commonly used in combination with general anesthesia or as the sole anesthetic technique, particularly in plastic, orthopedic and vascular surgeries to reduce the amount of anesthetic and analgesic agents needed, minimize systemic side effects, improve recovery, provide better postoperative pain relief, and shorten hospital stays.
The cervical plexus is made up of the ventral rami of the C1-C4 spinal nerves. The cervical plexus consists of motor (phrenic nerve, direct muscle branches) and terminal sensory branches (C2-C4): the supraclavicular nerves, the lesser occipital nerve, greater auricular nerve, and transverse cervical nerve. The latter is formed in the compartment between the prevertebral and superficial layer of the cervical fascia, deep to the sternocleidomastoid. Before 2004, any cervical plexus blocks that were performed superficially to the prevertebral fascia were termed superficial cervical plexus blocks. However, Telford and Stoneham suggested the term intermediate cervical plexus block to distinguish between the superficial block (subcutaneous or subplatysmal) and the block in the interfascial compartment. Intermediate cervical plexus block is a safe, popular, easy, and effective technique for regional analgesia of cervical region. The use of ultrasound guidance reduces the risk of complications, allows for real-time visualization of anatomical structures, and helps guide needle placement.
Bilateral cervical erector spinae block using ultrasound has recently been studied for shoulder surgery. Since the brachial plexus, phrenic nerves, cervical nerve roots, and deep cervical muscles are enclosed in the prevertebral fascia, injecting a local anesthetic near the cervical transverse process can spread to nearby structures within the prevertebral compartment. In a cadaver study, it was found that injecting a 20 mL dye solution into the transverse process of C6 or C7 resulted in staining of the C5-T1 nerve roots.
With the increasing number of nerve block techniques available, anesthesiologists may have difficulty determining the most appropriate technique to achieve optimal recovery after anterior cervical spine surgery. Therefore, this study will conducted to compare the efficacy of ultrasound-guided intermediate cervical plexus block and cervical erector spinae block in patients undergoing anterior cervical spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- All blocks will be conducted under sterile conditions in the operating room with sedation "midazolam 0.03-0.05 mg/kg as needed" 30 minutes before induction of general anesthesia. a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side
| Arm | Type | Receives |
|---|---|---|
| Intermediate cervical plexus block | Active comparator | Procedure: Block for Anterior Cervical Spine SurgeryThe patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side. |
| Cervical Erector spinae block | Active comparator | Procedure: Block for Anterior Cervical Spine SurgeryThe patient will be positioned laterally, with a pillow under their head. Transverse ultrasound scanning of the lower cervical area will be done. Starting from the supraclavicular brachial plexus, the transducer will be slid in a cephalic direction to show the transverse process of the C7 vertebra. Then, it will be moved further cephalic to display the transverse process of C6, along with its characteristic anterior and posterior tubercles. The transducer will be then slid posteriorly to show the posterior tubercle of C6, along with the posterior neck muscles above it (trapezius, levator scapula, and erector spinae). After prepping and draping the patient using aseptic technique, the needle will be inserted (in plane technique from posterior) until it will reach the posterior tubercle of C6. Then, a total volume of 15 ml of bupivacaine 0.25% will be injected bilaterally. The same steps will be repeated on the opposite side. |
| Control group | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both sex
- Age: between 21 and 60 years
- Physical status: belongs to American Society of Anesthesiologists (ASA) I, II
- Body mass index (BMI): from 25 to 30 kg/m2
- Type of surgery: elective anterior cervical spine surgery under general anesthesia
Key exclusion criteria (7 listed)
- Refusal of participation.
- local infection at the puncture site.
- Mental or physical disability.
- History of allergy to study drugs (bupivacaine, fentanyl).
- Hematological disorders including coagulation abnormalities.
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 |
|---|---|---|
| Block for Anterior Cervical Spine SurgeryThe patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side | Procedure or surgery | Cervical Erector spinae block, Intermediate cervical plexus block |
| Saline (NaCl 0,9 %) (placebo)Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally | Drug | Control group |
Primary outcome
change in postoperative pain intensity using Numerical Rating Scale
Time frame: (Day 1) 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperative
Numeric Rating Scale ( NRS) score, a commonly used 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme ( pain as bad as you can imagine or worst pain imaginable). The patient will be instructed to mark along the line to represent the intensity of pain currently being experienced.
3 secondary outcomes
Change in the time of performance of the technique in minutes.
Time frame: Perioperative/Periprocedural
Change in the time to the first call for analgesia (nalbuphine) in hours.
Time frame: Perioperative/Periprocedural
The total measure of nalbuphine given to each patient during the first 24 hours of the postoperative period
Time frame: Perioperative/Periprocedural
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 10 Mar 2025.
- Results publication: PubMed 38649826Kamel AAF, Fahmy AM, Fathi HM, Elmesallamy WAEA, Khalifa OYA. Regional analgesia using ultrasound-guided intermediate cervical plexus block versus cervical erector spinae block for anterior cervical spine surgery: a randomized trial. BMC Anesthesiol. 2024 Apr 22;24(1):153. doi: 10.1186/s12871-024-02533-6.
- Results publication: PubMed 36894055Abdelhaleem NF, Youssef EM, Hegab AS. Analgesic efficacy of inter-semispinal fascial plane block in Patients undergoing Cervical Spine Surgery through Posterior Approach: a randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101213. doi: 10.1016/j.accpm.2023.101213. Epub 2023 Mar 7.
- Related InfoLink provided by the sponsor.
- 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.
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 Block for Anterior Cervical Spine Surgery in people with Anesthesia, Local, run by Tanta 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 5 inclusion and 7 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 10 Mar 2025. 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?
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 mohammed A khodair, master (+201004881505, khodair1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in postoperative pain intensity using Numerical Rating Scale (time frame: (Day 1) 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867510, which also lists 2 linked publications.
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 10 Mar 2025.