Erector Spinae Plane BlockNCT04947644
Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy
A study testing Thoracic epidural analgesia and Ultrasound guided continuous erector spinae plane block in people with Erector Spinae Plane Block and Thoracic Epidural Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Thoracic Epidural Analgesia, Nephrectomy
- What is being tested?
- Thoracic epidural analgesia and Ultrasound guided continuous erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 15 Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class II.
- Patients undergoing open nephrectomy for malignant renal tumors.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Who cannot join
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelet count below 50,000 or an international normalized ratio >1.6.
- Renal and hepatic insufficiency.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
- Abnormal anatomy of the thoracic region.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Atef Badran, MD, +(202) 2532 82 86, irb@nci.cu.edu.eg
About this study
Official title: Comparative Study of Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy for Renal Malignancy: A Randomized Controlled Study.
There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.
Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.
The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.
Read the detailed description
The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane. Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.
Cadaveric studies was done on ESPB using MRI to evaluate the spread of local anesthetic mixed with gadolinium dye. Showed the spread of injected volume of 30 ml at level of T10 spread between the level of T5 and T12 . Other cadaveric study showed the spread of the dye to thoracic paravertebral space which may explain the visceral analgesic effect of the block.
There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.
Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.
The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.
- Being tested
- Thoracic epidural analgesia, Ultrasound guided continuous erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural analgesiaProcedure or surgery
After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
Ultrasound guided continuous erector spinae plane blockProcedure or surgery
After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural analgesia group | Active comparator | After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects Receives: Procedure: Thoracic epidural analgesia |
| Ultrasound guided continuous erector spinae plane block group | Experimental | After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects Receives: Procedure: Ultrasound guided continuous erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption within 24 hours postoperative
Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3. The total amount of morphine given in 24 hours will be recorded for every patient.
Measured: First 24 hours postoperatively.
Secondary outcomes (10)
Total intra-operative fentanyl consumption.
Elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg
Measured: Intra-operative
The time of first rescue analgesia.
Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3
Measured: First 24 hours postoperatively.
Pain using Numerical rating scale (NRS) at rest
Pain scores using NRS will be recorded in the post anaesthesia care unit , and for the next 24 hours (1, 2, 4, 6, 12 and 24h) postoperatively. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain.
Measured: First 24 hours postoperatively.
Pain using Numerical rating scale (NRS) during movement
Pain scores using NRS will be recorded in the post anaesthesia care unit , and for the next 24 hours (1, 2, 4, 6, 12 and 24h) postoperatively. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain.
Measured: First 24 hours postoperatively.
Changes in Intraoperative heart rate
It will be recorded before injection of the local anesthetics to be defined as a baseline reading and follow up after injection then will be recorded immediately before and after surgical incision and at 30 min intervals intraoperatively.
Measured: Intraoperatively
Changes in Intraoperative mean arterial pressure
It will be recorded before injection of the local anesthetics to be defined as a baseline reading and follow up after injection then will be recorded immediately before and after surgical incision and at 30 min intervals intraoperatively.
Measured: Intraoperatively
Changes in postoperative mean arterial blood pressure
It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
Measured: First 24 hours postoperatively.
Changes in postoperative heart rate
It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
Measured: First 24 hours postoperatively.
Total dose of bupivacaine consumption.
In thoracic epidural analgesia group 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given.
In erector spinae plane block group 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given.
In both groups:
Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
Measured: First 24 hours postoperatively.
The incidence of various side effects .
such as hemodynamic instability, nausea, vomiting, dural puncture with the needle or the catheter, post dural puncture headache, failed block, unintentional intravascular injection of local anesthetic, local anesthetic toxicity and respiratory depression (respiratory rate <10/minute) will be recorded
Measured: Intra-operative and 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 posted1 Jul 2021
- Study start15 Jul 2021
- Primary completion14 May 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Abd elgalil, MD, Principal investigator, Assistant Lecturer of Anesthesia ,Pain Relief and ICU National Cancer Institute ,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947644
- Sponsor's protocol ID
- 2015-301-015
- Status last verified
- Dec 2021
- First submitted
- 23 Jun 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy for Renal Malignancy: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04947644
- Acronym / sponsor ID
- 2015-301-015
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 14 May 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 1 Jul 2021 (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 different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.
Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.
The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.
Detailed description
The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane. Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.
Cadaveric studies was done on ESPB using MRI to evaluate the spread of local anesthetic mixed with gadolinium dye. Showed the spread of injected volume of 30 ml at level of T10 spread between the level of T5 and T12 . Other cadaveric study showed the spread of the dye to thoracic paravertebral space which may explain the visceral analgesic effect of the block.
There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.
Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.
The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural analgesia group | Active comparator | Procedure: Thoracic epidural analgesiaAfter negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects |
| Ultrasound guided continuous erector spinae plane block group | Experimental | Procedure: Ultrasound guided continuous erector spinae plane blockAfter verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists class II.
- Patients undergoing open nephrectomy for malignant renal tumors.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Key exclusion criteria (8 listed)
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelet count below 50,000 or an international normalized ratio >1.6.
- Renal and hepatic insufficiency.
- Unstable cardiovascular disease.
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 analgesiaAfter negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects | Procedure or surgery | Thoracic epidural analgesia group |
| Ultrasound guided continuous erector spinae plane blockAfter verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects | Procedure or surgery | Ultrasound guided continuous erector spinae plane block group |
Primary outcome
Total morphine consumption within 24 hours postoperative
Time frame: First 24 hours postoperatively.
Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3. The total amount of morphine given in 24 hours will be recorded for every patient.
10 secondary outcomes
Total intra-operative fentanyl consumption.
Time frame: Intra-operative
The time of first rescue analgesia.
Time frame: First 24 hours postoperatively.
Pain using Numerical rating scale (NRS) at rest
Time frame: First 24 hours postoperatively.
Pain using Numerical rating scale (NRS) during movement
Time frame: First 24 hours postoperatively.
Changes in Intraoperative heart rate
Time frame: Intraoperatively
Changes in Intraoperative mean arterial pressure
Time frame: Intraoperatively
Changes in postoperative mean arterial blood pressure
Time frame: First 24 hours postoperatively.
Changes in postoperative heart rate
Time frame: First 24 hours postoperatively.
Total dose of bupivacaine consumption.
Time frame: First 24 hours postoperatively.
The incidence of various side effects .
Time frame: Intra-operative and first 24 hours postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author.
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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.
Mahmoud Abd elgalil, MD principal investigator
Assistant Lecturer of Anesthesia ,Pain Relief and ICU National Cancer Institute ,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 Thoracic epidural analgesia and Ultrasound guided continuous erector spinae plane block in people with Erector Spinae Plane Block and Thoracic Epidural Analgesia, run by National Cancer Institute, Egypt 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 8 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 14 Jan 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. 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 Mahmoud Abd elgalil, MD (00201285332068, dr.ma7moud-abdelgilil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption within 24 hours postoperative (time frame: First 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 14 Jan 2022.