Pain, PostoperativeNCT04537598
Erector Spinae Plane Block for Post-nephrectomy Pain
A study testing Erector Spinae plane block in people with Pain, Postoperative, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. It may also predispose patients to chronic post-surgical pain .Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2020to 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
- Physical status ASA II.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Who cannot join
- Patient refusal
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders.
- Localized infection at the site of block.
- Coagulopathies with platelet count below 50,000 or an INR>1.5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Continuous Erector Spinae Plane Block Versus Patient Controlled Analgesia in Patients Undergoing Nephrectomy for Renal Malignancies: A Randomized Controlled Study
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. It may also predispose patients to chronic post-surgical pain .Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection.Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain besides their side effects.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.
Read the detailed description
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. In addition to its early effects, poorly controlled acute postoperative pain may predispose patients to chronic post-surgical pain.
Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection, which is the main method for open nephrectomy at our institution, could make for better dissection of the renal pelvis and the pedicles, and provide the best circumstances for nephrectomy; however, it induces more persistent pain compared with other approaches.
Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain. In addition, opioids have many side effects like respiratory depression, nausea, vomiting and constipation hence it is important to decrease opioids use and the transition to other modalities such as regional blocks, nerve blocks, NSAIDs and multimodalities.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.
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.
There are different case studies about the use of erector spinae block in nephrectomy but there is no randomized controlled study 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.
The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.
- Conditions
- Pain, Postoperative
- Being tested
- Morphine patient controlled analgesia, Erector Spinae plane 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.
Morphine patient controlled analgesiaProcedure or surgery
30 patients will receive PCA only for postoperative analgesia
Erector Spinae plane blockProcedure or surgery
30 patients will receive continuous ESPB for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| patient controlled analgesia | Active comparator | 30 patients will receive only postoperative IV PCA alone for postoperative analgesia. Receives: Procedure: Morphine patient controlled analgesia |
| Erector Spinae plane block | Active comparator | 30 patients will receive continuous ESPB for postoperative analgesia. Receives: Procedure: Erector Spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of visual analogue score
it is a scoring system from 0 to 100 mm where 100 represents the worst pain and 0 indicates no pain
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start3 Mar 2020
- Primary completion28 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Gendy, MD, Principal investigator, Assistant Professor of Anesthesia, intensive care and pain releif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537598
- Sponsor's protocol ID
- ESPB for nephrectomy
- Status last verified
- Jul 2022
- First submitted
- 28 Aug 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we can share IPD after journal accepting the manuscript
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Continuous Erector Spinae Plane Block Versus Patient Controlled Analgesia in Patients Undergoing Nephrectomy for Renal Malignancies: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04537598
- Acronym / sponsor ID
- ESPB for nephrectomy
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 3 Sep 2020 (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.
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. It may also predispose patients to chronic post-surgical pain .Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection.Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain besides their side effects.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.
Detailed description
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. In addition to its early effects, poorly controlled acute postoperative pain may predispose patients to chronic post-surgical pain.
Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection, which is the main method for open nephrectomy at our institution, could make for better dissection of the renal pelvis and the pedicles, and provide the best circumstances for nephrectomy; however, it induces more persistent pain compared with other approaches.
Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain. In addition, opioids have many side effects like respiratory depression, nausea, vomiting and constipation hence it is important to decrease opioids use and the transition to other modalities such as regional blocks, nerve blocks, NSAIDs and multimodalities.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.
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.
There are different case studies about the use of erector spinae block in nephrectomy but there is no randomized controlled study 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.
The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient controlled analgesia | Active comparator | Procedure: Morphine patient controlled analgesia30 patients will receive only postoperative IV PCA alone for postoperative analgesia. |
| Erector Spinae plane block | Active comparator | Procedure: Erector Spinae plane block30 patients will receive continuous ESPB for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physical status ASA II.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Key exclusion criteria (5 listed)
- Patient refusal
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders.
- Localized infection at the site of block.
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 |
|---|---|---|
| Morphine patient controlled analgesia30 patients will receive PCA only for postoperative analgesia | Procedure or surgery | patient controlled analgesia |
| Erector Spinae plane block30 patients will receive continuous ESPB for postoperative analgesia | Procedure or surgery | Erector Spinae plane block |
Primary outcome
measurement of visual analogue score
Time frame: 1 week
it is a scoring system from 0 to 100 mm where 100 represents the worst pain and 0 indicates no pain
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 21 Jul 2022.
- Individual participant dataSharing planned: No. we can share IPD after journal accepting the manuscript
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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.
Ehab H Gendy, MD principal investigator
Assistant Professor of Anesthesia, intensive care and pain releif
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 in people with Pain, Postoperative, 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 5 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 21 Jul 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?
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?
measurement of visual analogue score (time frame: 1 week). 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 21 Jul 2022.