Post-thoracotomy Pain SyndromeNCT05791539
Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain
A study testing Erector spinae plane block and erector spinae plane block + retrolaminar block in people with Post-thoracotomy Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-thoracotomy Pain Syndrome
- What is being tested?
- Erector spinae plane block and erector spinae plane block + retrolaminar block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2023to Nov 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Inclusion criteria
- Age from 18-65 years.
- body mass index (BMI) ranged between 20 and 40 kg/m2
- ASA I, II patients undergoing open thoracic surgery through a posterolateral thoracotomy 2. Exclusion criteria
- Patient refusal.
- Sensitivity or contraindication to local anesthetic drugs.
Show all 9Show fewer
- History of psychological disorders and/or chronic pain.
- Localized infection at the site of the block.
- Coagulopathies, patients on anticoagulants and antiplatelets, and significant liver or renal insufficiency
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unviersity
Cairo
Sherif M Abbas, MD, 0201141235049 ext. 002, s25041989@hotmail.com
About this study
Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain
Read the detailed description
Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality.
The surgical incision produces post-thoracotomy pain (PTP) via damage to the ribs and intercostal nerves, inflammation of the chest wall, pleura or pulmonary parenchyma cutting, and placement of the intercostal chest tube. Acute PTP inhibits the ability to breathe and cough normally. Numerous analgesic techniques are used to relieve PTP, including systemic opioids, regional techniques (such as paravertebral nerve blockade, intercostal nerve blockade, intrapleural analgesia, and epidural opioids with or without local analgesia), cryo-analgesia, and transcutaneous electrical nerve stimulation (TENS).
Emerging research has shown that the novel erector spinae plane block (ESPB) can be employed as a simple and safe alternative analgesic technique for acute post-surgical, post-traumatic, and chronic neuropathic thoracic pain in adults.
ESPB was first reported in 2016 for ipsilateral thoracic analgesia. It was found to be a safe and effective block that can be performed by an emergency physician in the emergency department setting for addressing acute pain due to multiple rib fractures.
Retrolaminar block (RLB) was first reported in 2006 as an alternative approach to PVB. RLB is performed with US imaging or the landmark technique. The efficacy of continuous RLB has been reported for breast cancer surgery .
However, the efficacy of ESPB has been described in a greater number of clinical reports than has RLB: a rib fracture, breast surgery, thoracoscopic surgery, lumbar spinal surgery, and laparoscopic abdominal surgery. In contrast to RLB, most of the literature on ESPB reported the use of the single-shot technique (80.2%). The local anesthetic was postulated to infiltrate the ventral and dorsal rami of the spinal nerve. However, Ueshima et al. reported that ESPB could not provide adequate analgesia of the anterior branch of the intercostal nerve.
The rationale of the study is that to the best of our knowledge each of ESPB and RLB has limitations regarding sensory block and distribution so our hypothesis is combining both will provide more solid block regarding sensory distribution, time interval of the block efficacy, and postoperative morphine consumption in patients undergoing thoracic surgeries.
Few studies evaluated the efficacy of ultrasound (US) guided erector spinae plane block on post-thoracotomy analgesia, however for the best of our knowledge no one compared the effect of ultrasound (US) guided retrolaminar block combined with erector spinae plane block and ultrasound (US) guided erector spinae plane block alone in patients undergoing thoracic surgeries.
- Conditions
- Post-thoracotomy Pain Syndrome
- Being tested
- Erector spinae plane block, erector spinae plane block + retrolaminar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.
erector spinae plane block + retrolaminar blockProcedure or surgery
Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Erector spinae plane block | Experimental | Group 1 (ESPB (control group): (n = 15) patients will receive preoperative US-guided ESPB on the operated side by 20 ml bupivacaine 0.25%. Receives: Procedure: Erector spinae plane block |
| Group 2: Erector spinae plane block | Experimental | US-guided ESPB with 10 ml bupivacaine 0.25% (n = 15) on the operated side. Receives: Procedure: Erector spinae plane block |
| Retro laminar block | Experimental | the US-guided retrolaminar block 10 ml bupivacaine 0.25% group: (n = 15) on the operated side. Receives: Procedure: erector spinae plane block + retrolaminar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of morphine consumption in the first 24-hour postoperative in the two groups.
20ml for ESPB compared to 10ml ESPB added to 10ml RLB.
Measured: 24 hours
Secondary outcomes (5)
•Pain score according to VAS score
Pain score according to VAS score at 30min, 2h, 4h, 8h, 12h, 24h postoperative.
Measured: 24 hours
• Heart rate
- Heart rate(Bpm) at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.
Measured: intraoperative
Incidence of complications
•Incidence of complications as hypotension, bradycardia, postoperative nausea, vomiting (PONV) and pruritis.
Measured: 24 hours
.First request of analgesia postoperative
first time to request analgesia in the first 24 hrs
Measured: 24 hours
MAP
Mean arterial blood pressure in mmhg at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start2 Feb 2023
- Primary completion12 Oct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sherif Mamdouh Abbas, Cairo University
- Investigators
- sherif mamdouh, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791539
- Sponsor's protocol ID
- MS-397-2022
- Status last verified
- Aug 2023
- First submitted
- 16 Dec 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain
- ClinicalTrials.gov ID
- NCT05791539
- Acronym / sponsor ID
- MS-397-2022
- Conditions
- Post-thoracotomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 12 Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 30 Mar 2023 (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.
Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain
Detailed description
Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality.
The surgical incision produces post-thoracotomy pain (PTP) via damage to the ribs and intercostal nerves, inflammation of the chest wall, pleura or pulmonary parenchyma cutting, and placement of the intercostal chest tube. Acute PTP inhibits the ability to breathe and cough normally. Numerous analgesic techniques are used to relieve PTP, including systemic opioids, regional techniques (such as paravertebral nerve blockade, intercostal nerve blockade, intrapleural analgesia, and epidural opioids with or without local analgesia), cryo-analgesia, and transcutaneous electrical nerve stimulation (TENS).
Emerging research has shown that the novel erector spinae plane block (ESPB) can be employed as a simple and safe alternative analgesic technique for acute post-surgical, post-traumatic, and chronic neuropathic thoracic pain in adults.
ESPB was first reported in 2016 for ipsilateral thoracic analgesia. It was found to be a safe and effective block that can be performed by an emergency physician in the emergency department setting for addressing acute pain due to multiple rib fractures.
Retrolaminar block (RLB) was first reported in 2006 as an alternative approach to PVB. RLB is performed with US imaging or the landmark technique. The efficacy of continuous RLB has been reported for breast cancer surgery .
However, the efficacy of ESPB has been described in a greater number of clinical reports than has RLB: a rib fracture, breast surgery, thoracoscopic surgery, lumbar spinal surgery, and laparoscopic abdominal surgery. In contrast to RLB, most of the literature on ESPB reported the use of the single-shot technique (80.2%). The local anesthetic was postulated to infiltrate the ventral and dorsal rami of the spinal nerve. However, Ueshima et al. reported that ESPB could not provide adequate analgesia of the anterior branch of the intercostal nerve.
The rationale of the study is that to the best of our knowledge each of ESPB and RLB has limitations regarding sensory block and distribution so our hypothesis is combining both will provide more solid block regarding sensory distribution, time interval of the block efficacy, and postoperative morphine consumption in patients undergoing thoracic surgeries.
Few studies evaluated the efficacy of ultrasound (US) guided erector spinae plane block on post-thoracotomy analgesia, however for the best of our knowledge no one compared the effect of ultrasound (US) guided retrolaminar block combined with erector spinae plane block and ultrasound (US) guided erector spinae plane block alone in patients undergoing thoracic surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Erector spinae plane block | Experimental | Procedure: Erector spinae plane blockGroup 1 (ESPB (control group): (n = 15) patients will receive preoperative US-guided ESPB on the operated side by 20 ml bupivacaine 0.25%. |
| Group 2: Erector spinae plane block | Experimental | Procedure: Erector spinae plane blockUS-guided ESPB with 10 ml bupivacaine 0.25% (n = 15) on the operated side. |
| Retro laminar block | Experimental | Procedure: erector spinae plane block + retrolaminar blockthe US-guided retrolaminar block 10 ml bupivacaine 0.25% group: (n = 15) on the operated side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Inclusion criteria
Key exclusion criteria (0 listed)
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 spinae plane blockPatients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA. | Procedure or surgery | Group 1 Erector spinae plane block, Group 2: Erector spinae plane block |
| erector spinae plane block + retrolaminar blockPatients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA. | Procedure or surgery | Retro laminar block |
Primary outcome
Total amount of morphine consumption in the first 24-hour postoperative in the two groups.
Time frame: 24 hours
20ml for ESPB compared to 10ml ESPB added to 10ml RLB.
5 secondary outcomes
•Pain score according to VAS score
Time frame: 24 hours
• Heart rate
Time frame: intraoperative
Incidence of complications
Time frame: 24 hours
.First request of analgesia postoperative
Time frame: 24 hours
MAP
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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.
sherif mamdouh, MD principal investigator
Cairo 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 Erector spinae plane block and erector spinae plane block + retrolaminar block in people with Post-thoracotomy Pain Syndrome, run by Cairo 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 9 inclusion and 0 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 30 Aug 2023. 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 sherif mamdouh, MD (01141235049 ext. 002, s25041989@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of morphine consumption in the first 24-hour postoperative in the two groups. (time frame: 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 30 Aug 2023.