Postoperative AnalgesiaNCT05507281
Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Thoracotomy
A study testing Ultrasound-guided Erector Spinae Plane Block and Retrolaminar Block in people with Postoperative Analgesia and Retrolaminar Block, run by Tanta University at 1 site in Egypt.
Trial summary
Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia, Retrolaminar Block, Ultrasound-guided Erector Spinae Plane Block
- What is being tested?
- Ultrasound-guided Erector Spinae Plane Block and Retrolaminar Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 21-65 years old of both sexes.
- Patients were scheduled for elective thoracotomy.
- Their ASA physical status classification is II-III.
Who cannot join
- Patients' refusal.
- Local infection at the site of block.
- Coagulation abnormalities.
- Sever spinal deformity e.g. scoliosis.
- Known hypersensitivity to local anesthetics.
- Mental dysfunction and cognitive disorders.
- History of drug abuse and chronic analgesic use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
Read the detailed description
Thoracotomy is one of the most painful surgical procedures. The reported incidence of persistent pain after thoracic surgery (post thoracotomy pain syndrome) has been reported in 20%-70% of patients. Inadequately treated post thoracotomy pain can have several negative consequences. Therefore, pain relief is essential to facilitate coughing and deep breathing and to promote early mobilization.
Thoracic epidural analgesia and thoracic paravertebral block are strongly recommended techniques for managing post thoracotomy pain to reduce opioid use and the related adverse effects as hypoventilation, depression of cough reflex, nausea and vomiting. However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia and potential risk of pneumothorax in thoracic paravertebral block.
Erector spinae plane block is a relatively novel ultrasound-guided regional technique. Its application in patients with chronic thoracic neuropathic pain and acute surgical pain has been described by Forero et al.
Retrolaminar block is an easy and safe analgesic technique. It has been reported to be satisfactory for post-operative analgesia after breast surgery.
To our knowledge there is no clinical studies, comparing the effectiveness of both blocks on postthoracotomy pain, has been reported.
- Conditions
- Postoperative Analgesia, Retrolaminar Block, Ultrasound-guided Erector Spinae Plane Block, Thoracotomy
- Being tested
- Ultrasound-guided Erector Spinae Plane Block, Retrolaminar Block, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Erector Spinae Plane BlockProcedure or surgery
ultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
Retrolaminar BlockProcedure or surgery
ultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).
ControlProcedure or surgery
General anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Patients received general anesthesia alone. Receives: Procedure: Control |
| Ultrasound-guided Erector Spinae Plane Block | Experimental | A 22-gauge needle is inserted at a puncture site lateral to the target spinous process using ultrasound imaging and advanced until contact is made with the transverse process. The local anesthetic agent will be injected between the transverse process and the erector spinae muscle using 20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg). Receives: Procedure: Ultrasound-guided Erector Spinae Plane Block |
| Retrolaminar Block | Experimental | A 22-gauge needle is inserted at a puncture site lateral to the target spinous process using ultrasound imaging and advanced caudally or cranially until it contacts the lamina. The local anesthetic agent will be injected on the lamina using 20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg). Receives: Procedure: Retrolaminar Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
The Numeric Pain Rating Scale is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain). Postoperative pain will be assessed at emergence and 2nd, 4th, 8th, 12th, 18th and 24th hour postoperatively.
Measured: 24 hours postoperatively.
Secondary outcomes (2)
The time of first analgesic request
The time of first analgesic request. IV morphine sulphate 0.05 mg/kg will be administered as rescue analgesic if Numeric Pain Rating Scale is ≥ 4.
Measured: 24 hours postoperatively
The total amount of morphine
The total amount of morphine consumption in the first 24 hours postoperatively.
Measured: 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 posted18 Aug 2022
- Study start1 Aug 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly allocated into 3 equal groups (Control group, Ultrasound-guided Erector Spinae Plane Block group, Retrolaminar Block, 20 patients each) through sealed envelopes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Adel Momen Elshazly, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507281
- Sponsor's protocol ID
- 34580/3/21
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT05507281
- Acronym / sponsor ID
- 34580/3/21
- Conditions
- Postoperative Analgesia, Retrolaminar Block, Ultrasound-guided Erector Spinae Plane Block, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Aug 2022 (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.
Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
Detailed description
Thoracotomy is one of the most painful surgical procedures. The reported incidence of persistent pain after thoracic surgery (post thoracotomy pain syndrome) has been reported in 20%-70% of patients. Inadequately treated post thoracotomy pain can have several negative consequences. Therefore, pain relief is essential to facilitate coughing and deep breathing and to promote early mobilization.
Thoracic epidural analgesia and thoracic paravertebral block are strongly recommended techniques for managing post thoracotomy pain to reduce opioid use and the related adverse effects as hypoventilation, depression of cough reflex, nausea and vomiting. However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia and potential risk of pneumothorax in thoracic paravertebral block.
Erector spinae plane block is a relatively novel ultrasound-guided regional technique. Its application in patients with chronic thoracic neuropathic pain and acute surgical pain has been described by Forero et al.
Retrolaminar block is an easy and safe analgesic technique. It has been reported to be satisfactory for post-operative analgesia after breast surgery.
To our knowledge there is no clinical studies, comparing the effectiveness of both blocks on postthoracotomy pain, has been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients were randomly allocated into 3 equal groups (Control group, Ultrasound-guided Erector Spinae Plane Block group, Retrolaminar Block, 20 patients each) through sealed envelopes.
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: ControlPatients received general anesthesia alone. |
| Ultrasound-guided Erector Spinae Plane Block | Experimental | Procedure: Ultrasound-guided Erector Spinae Plane BlockA 22-gauge needle is inserted at a puncture site lateral to the target spinous process using ultrasound imaging and advanced until contact is made with the transverse process. The local anesthetic agent will be injected between the transverse process and the erector spinae muscle using 20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg). |
| Retrolaminar Block | Experimental | Procedure: Retrolaminar BlockA 22-gauge needle is inserted at a puncture site lateral to the target spinous process using ultrasound imaging and advanced caudally or cranially until it contacts the lamina. The local anesthetic agent will be injected on the lamina using 20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 21-65 years old of both sexes.
- Patients were scheduled for elective thoracotomy.
- Their ASA physical status classification is II-III.
Key exclusion criteria (7 listed)
- Patients' refusal.
- Local infection at the site of block.
- Coagulation abnormalities.
- Sever spinal deformity e.g. scoliosis.
- Known hypersensitivity to local anesthetics.
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 |
|---|---|---|
| Ultrasound-guided Erector Spinae Plane Blockultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)). | Procedure or surgery | Ultrasound-guided Erector Spinae Plane Block |
| Retrolaminar Blockultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)). | Procedure or surgery | Retrolaminar Block |
| ControlGeneral anesthesia | Procedure or surgery | Control group |
Primary outcome
Pain assessment
Time frame: 24 hours postoperatively.
The Numeric Pain Rating Scale is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain). Postoperative pain will be assessed at emergence and 2nd, 4th, 8th, 12th, 18th and 24th hour postoperatively.
2 secondary outcomes
The time of first analgesic request
Time frame: 24 hours postoperatively
The total amount of morphine
Time frame: 24 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 29 Aug 2022.
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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 study testing Ultrasound-guided Erector Spinae Plane Block and Retrolaminar Block in people with Postoperative Analgesia and Retrolaminar Block, 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 3 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 29 Aug 2022. 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.
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?
Pain assessment (time frame: 24 hours postoperatively.). 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 29 Aug 2022.