Post Operative PainTEAVSESPBNCT06571188
Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia
A study testing THORACIC EPIDURAL BLOCK and ERECTOER SPINE BLOCK in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- THORACIC EPIDURAL BLOCK and ERECTOER SPINE BLOCK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 10 Dec 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.
Who cannot join
- Patients who are:
- Unable to cooperate.
- Patients who have allergy to any of the study drugs.
- Patients who are on opioids.
- Local infection at the site of injection or systemic infection.
- Patients with coagulation disorders or on anticoagulation therapy Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder
- Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Postoperative Analgesia Following Thoracotomy Surgeries: a Randomised Trial
There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose
Read the detailed description
The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.
The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively
- Conditions
- Post Operative Pain
- Being tested
- THORACIC EPIDURAL BLOCK, ERECTOER SPINE BLOCK
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THORACIC EPIDURAL BLOCKOther
Also called TEB
In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with fentanyl 1 μg/ml.].
ERECTOER SPINE BLOCKOther
Also called ESPB
The ESP block will be performed as described by Forero et al
| Study group | Role | What they receive |
|---|---|---|
| TEB GROUP | Active comparator | In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with Fentanyl 1 μg/ml.]. Receives: Other: THORACIC EPIDURAL BLOCK |
| ESPB group | Active comparator | In group ESPB, The ESP block will be performed as described by Forero et al. A Tuohy needle will be inserted with an in-plane technique in a caudal to cephalad direction until bony contact with the transverse process is obtained. Hydro dissection with normal saline will be performed to identify and open up the correct plane for injection. A loading dose of Bupivacaine will be injected followed by the insertion of an 18-g catheter 5 cm beyond the needle tip. No further local anaesthetic will be administered intra-operatively. Following the end of surgery, a continuous infusion of 5 ml/h of Bupivacaine 0.125%, supplemented by a 10-ml bolus injection every 3 h, will be administered through the ESPB catheter Receives: Other: ERECTOER SPINE BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
MORPHINE CONSUMPTION
cumulative 24 h opioid (morphine) consumption
Measured: 24 hours
Numeric rating scale
is an 11-point scale scored from 0-10:
- "0" = no pain
- "10" = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.
Measured: 24 hours
Secondary outcomes (4)
Time for first rescue analgesia
Time for first rescue analgesia will be measured and recorded
Measured: 24 hours
The number of rescue analgesics
the number of rescue analgesics within 24hrs after surgery will be recorded
Measured: 24 hours
Time to ambulation
Time to ambulation WILL BE RECOREDED
Measured: 24 hours
Complications
Complications like bradycardia or hypotension, itching, nausea and vomiting will be recorded.
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 posted26 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- AMAL G SAFAN, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571188
- Sponsor's protocol ID
- 8/2024ANET6-1
- Acronym
- TEAVSESPB
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habeeb RM, Sultan WA, Basune ME, Safan AG. Continuous Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoracotomy. Clin J Pain. 2026 Oct 1;42(10):e1399. doi: 10.1097/AJP.0000000000001399.
PubMed 42145113
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Postoperative Analgesia Following Thoracotomy Surgeries: a Randomised Trial
- ClinicalTrials.gov ID
- NCT06571188
- Acronym / sponsor ID
- TEAVSESPB / 8/2024ANET6-1
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 26 Aug 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.
There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose
Detailed description
The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.
The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug
| Arm | Type | Receives |
|---|---|---|
| TEB GROUP | Active comparator | Other: THORACIC EPIDURAL BLOCKIn group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with Fentanyl 1 μg/ml.]. |
| ESPB group | Active comparator | Other: ERECTOER SPINE BLOCKIn group ESPB, The ESP block will be performed as described by Forero et al. A Tuohy needle will be inserted with an in-plane technique in a caudal to cephalad direction until bony contact with the transverse process is obtained. Hydro dissection with normal saline will be performed to identify and open up the correct plane for injection. A loading dose of Bupivacaine will be injected followed by the insertion of an 18-g catheter 5 cm beyond the needle tip. No further local anaesthetic will be administered intra-operatively. Following the end of surgery, a continuous infusion of 5 ml/h of Bupivacaine 0.125%, supplemented by a 10-ml bolus injection every 3 h, will be administered through the ESPB catheter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.
Key exclusion criteria (7 listed)
- Patients who are:
- Unable to cooperate.
- Patients who have allergy to any of the study drugs.
- Patients who are on opioids.
- Local infection at the site of injection or systemic infection.
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 |
|---|---|---|
| THORACIC EPIDURAL BLOCKAlso: TEBIn group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with fentanyl 1 μg/ml.]. | Other | TEB GROUP |
| ERECTOER SPINE BLOCKAlso: ESPBThe ESP block will be performed as described by Forero et al | Other | ESPB group |
Primary outcome
MORPHINE CONSUMPTION
Time frame: 24 hours
cumulative 24 h opioid (morphine) consumption
Numeric rating scale
Time frame: 24 hours
is an 11-point scale scored from 0-10: 1. "0" = no pain 2. "10" = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.
4 secondary outcomes
Time for first rescue analgesia
Time frame: 24 hours
The number of rescue analgesics
Time frame: 24 hours
Time to ambulation
Time frame: 24 hours
Complications
Time frame: 24 hours
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 20 Mar 2025.
- Derived from this study: PubMed 42145113Habeeb RM, Sultan WA, Basune ME, Safan AG. Continuous Ultrasound-guided Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoracotomy. Clin J Pain. 2026 Oct 1;42(10):e1399. doi: 10.1097/AJP.0000000000001399.
- 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.
AMAL G SAFAN, MD principal investigator
Menoufia 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 THORACIC EPIDURAL BLOCK and ERECTOER SPINE BLOCK in people with Post Operative Pain, run by Menoufia 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 1 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: finished, as of the sponsor's last update on 20 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. 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?
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?
MORPHINE 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?
On the ClinicalTrials.gov record for NCT06571188, which also lists 1 linked publication.
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 20 Mar 2025.