Postoperative PainNCT06336161
Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection
A study testing Fentanyl in people with Postoperative Pain, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 May 2025
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing lumbosacral spine surgeries from (L4-L5) level to end of spinal cord.
- American society of anesthesiologists' classification (ASA) I \& II.
Who cannot join
- Patient's refusal.
- History of any previous back surgeries.
- History of any spinal cord deformities e.g., Scoliosis, Lordosis, Kyphosis, Ankylosing Spondylitis
- Bleeding disorders (platelets count < 80,000; International normalized ratio >1.4; PC< 70%) and coagulopathies.
- Skin lesion, wounds, or infection at the injection site.
- Known allergy to local anesthetic drugs.
Show all 9Show fewer
- Peripheral and Central Neuropathy.
- Patients with pre-operative opioid consumption.
- Chronic opioids or analgesics users.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University hospitals
Cairo
Mohamed Khalil, Resident, +201001297071, khalil.mohamed24mkh@gmail.com
About this study
Official title: Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques
Read the detailed description
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
Major lumbosacral surgery results in considerable postoperative discomfort that normally lasts at least three days. According to several research, the most discomfort occurs in the first four postoperative hours and gradually decreases by the third postoperative day. Efficient and safe postoperative analgesic treatments following lumbosacral surgery are useful for early recovery and hence required.
Traditional caudal epidural injections, on the other hand, pose a potential risk of epidural venous plexus or dura penetration, with the incidence of accidental intravascular injections, as confirmed by contrast enhanced fluoroscopy, ranging from 11 to 42% in patients who had received caudal epidural injections. Furthermore, there have been a few instances of unintended Dural puncture during the caudal approach because of an unusually low Dural sac termination in the sacral canal.
Such complications of intravascular and intrathecal drug injections might result in systemic toxicity of local anesthetics and complete spinal anesthesia. Thus, ultrasonography (US) can be utilized to guide caudal injections, increasing the efficacy of pain treatment while decreasing the risk of complications and incorrect injections. Previous investigations shown the feasibility of using ultrasound to locate the sacral hiatus and guide the needle into the caudal epidural area, with a reported success rate of 100%.
Another technique for postoperative pain relief is the Erector spinae plane block (ESPB), which was introduced in 2016. It is a relatively new regional anesthesia technique in which local anesthetic is injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has acquired favor in perioperative analgesia for a variety of surgical procedures, including breast, thoracic, abdominal, and lumbar spine operations.
The addition of US to ESPB allows the needle to be guided to efficiently deposit the anesthetic agents deep to the erector spinae muscle, resulting in the blockage of the ventral and dorsal rami of many spinal neurons, boosting the efficiency of pain control.
- Conditions
- Postoperative Pain
- Being tested
- Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called propofol 2Mg/Kg
to compare between Ultrasound-Guided ESPB and Ultrasound-Guided CEI for postoperative pain relief in patients who underwent lumbosacral surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Group A ( Erector Spinae Plane Block) | Active comparator | About 40 patients who will be subjected to Ultrasound-Guided Erector Spinae Plane Block.for Postoperative Pain Management Receives: Drug: Fentanyl |
| Group B (Caudal Injection) | Active comparator | About 40 patients who will be subjected to Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Post-operative Pain
Assessment of Pain after operations will be evaluated using the VAS consisting of a horizontal or vertical line, 10 centimeters long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status
Measured: the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalil Elsayed Khalil, Al-Azhar University
- Investigators
- Tarek Monir, Professor, Study chair, Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336161
- Sponsor's protocol ID
- ESPB versus CEI
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel Y, Ramachandran K, Shetty AP, Chelliah S, Subramanian B, Kanna RM, Shanmuganathan R. Comparison Between Relative Efficacy of Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Lumbar Fusion Surgery- A Prospective Randomized Controlled Study. Global Spine J. 2025 Mar;15(2):639-647. doi: 10.1177/21925682231203653. Epub 2023 Sep 22.
PubMed 37737097Shah M, Halalmeh DR, Sandio A, Tubbs RS, Moisi MD. Anatomical Variations That Can Lead to Spine Surgery at the Wrong Level: Part III Lumbosacral Spine. Cureus. 2020 Jul 28;12(7):e9433. doi: 10.7759/cureus.9433.
PubMed 32864257
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT06336161
- Acronym / sponsor ID
- ESPB versus CEI
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 28 Mar 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.
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques
Detailed description
Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
Major lumbosacral surgery results in considerable postoperative discomfort that normally lasts at least three days. According to several research, the most discomfort occurs in the first four postoperative hours and gradually decreases by the third postoperative day. Efficient and safe postoperative analgesic treatments following lumbosacral surgery are useful for early recovery and hence required.
Traditional caudal epidural injections, on the other hand, pose a potential risk of epidural venous plexus or dura penetration, with the incidence of accidental intravascular injections, as confirmed by contrast enhanced fluoroscopy, ranging from 11 to 42% in patients who had received caudal epidural injections. Furthermore, there have been a few instances of unintended Dural puncture during the caudal approach because of an unusually low Dural sac termination in the sacral canal.
Such complications of intravascular and intrathecal drug injections might result in systemic toxicity of local anesthetics and complete spinal anesthesia. Thus, ultrasonography (US) can be utilized to guide caudal injections, increasing the efficacy of pain treatment while decreasing the risk of complications and incorrect injections. Previous investigations shown the feasibility of using ultrasound to locate the sacral hiatus and guide the needle into the caudal epidural area, with a reported success rate of 100%.
Another technique for postoperative pain relief is the Erector spinae plane block (ESPB), which was introduced in 2016. It is a relatively new regional anesthesia technique in which local anesthetic is injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has acquired favor in perioperative analgesia for a variety of surgical procedures, including breast, thoracic, abdominal, and lumbar spine operations.
The addition of US to ESPB allows the needle to be guided to efficiently deposit the anesthetic agents deep to the erector spinae muscle, resulting in the blockage of the ventral and dorsal rami of many spinal neurons, boosting the efficiency of pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ( Erector Spinae Plane Block) | Active comparator | Drug: FentanylAbout 40 patients who will be subjected to Ultrasound-Guided Erector Spinae Plane Block.for Postoperative Pain Management |
| Group B (Caudal Injection) | Active comparator | Drug: FentanylAbout 40 patients who will be subjected to Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing lumbosacral spine surgeries from (L4-L5) level to end of spinal cord.
- American society of anesthesiologists' classification (ASA) I \& II.
Key exclusion criteria (9 listed)
- Patient's refusal.
- History of any previous back surgeries.
- History of any spinal cord deformities e.g., Scoliosis, Lordosis, Kyphosis, Ankylosing Spondylitis
- Bleeding disorders (platelets count < 80,000; International normalized ratio >1.4; PC< 70%) and coagulopathies.
- Skin lesion, wounds, or infection at the injection site.
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 |
|---|---|---|
| FentanylAlso: propofol 2Mg/Kgto compare between Ultrasound-Guided ESPB and Ultrasound-Guided CEI for postoperative pain relief in patients who underwent lumbosacral surgeries. | Drug | Group A ( Erector Spinae Plane Block), Group B (Caudal Injection) |
Primary outcome
Measurement of Post-operative Pain
Time frame: the first 24 hours postoperatively
Assessment of Pain after operations will be evaluated using the VAS consisting of a horizontal or vertical line, 10 centimeters long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Results publication: PubMed 37737097Patel Y, Ramachandran K, Shetty AP, Chelliah S, Subramanian B, Kanna RM, Shanmuganathan R. Comparison Between Relative Efficacy of Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Lumbar Fusion Surgery- A Prospective Randomized Controlled Study. Global Spine J. 2025 Mar;15(2):639-647. doi: 10.1177/21925682231203653. Epub 2023 Sep 22.
- Results publication: PubMed 32864257Shah M, Halalmeh DR, Sandio A, Tubbs RS, Moisi MD. Anatomical Variations That Can Lead to Spine Surgery at the Wrong Level: Part III Lumbosacral Spine. Cureus. 2020 Jul 28;12(7):e9433. doi: 10.7759/cureus.9433.
- Acute Postoperative Pain: Patient-Controlled AnalgesiaLink provided by the sponsor.
- Caudal epidural steroid injection ultrasound-guided versus fluoroscopy-guided in treatment of refractory lumbar disc prolapse with radiculopathyLink provided by the sponsor.
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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.
Tarek Monir, Professor study chair
Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Postoperative Pain, run by Al-Azhar 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khalil, Resident (+201001297071, khalil.mohamed24mkh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Post-operative Pain (time frame: the first 24 hours postoperatively). 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 NCT06336161, 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 28 Mar 2024.