Post Operative PainPhase 2/3NCT04118101
Erector Spinae Plane Block
A Phase 2/3 study testing ESPB block in people with Post Operative Pain, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Erector spinae plane block (ESPB) is a relatively new plane block that was first described by Forero et al. in 2016, to manage persistent neuropathic pain following malunited rib fracture and persistent post-thoracotomy neuropathic pain.It's a relatively simple, ultrasound guided block in which the local anesthetic… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ESPB block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2019to 15 Feb 2021
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient is able to provide a written informed consent.
- ASA I-II.
- Patient is scheduled to perform an elective open renal surgery through a flank incision.
Who cannot join
- ASA III-IV
- Pregnancy.
- Patient is allergic to bupivacaine local anesthetic.
- Impaired coagulation (Platelet count< 150,000 cells/mcl and/or INR ≥ 1.4).
- Infection at site of injection.
- Prior same side flank surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block for Patients Undergoing Open Renal Surgery Through Flank Incision: A Randomized Controlled Study.
Erector spinae plane block (ESPB) is a relatively new plane block that was first described by Forero et al. in 2016, to manage persistent neuropathic pain following malunited rib fracture and persistent post-thoracotomy neuropathic pain.It's a relatively simple, ultrasound guided block in which the local anesthetic drugs are injected in the plane between the erector spinae muscle and the vertebral transverse process.This allows the injected local anesthetics to block the ventral and dorsal rami of the spinal nerves in the paravertebral area.
The literature reveals successful case reports denoting the use of ESPB for pain control in cases of acute kidney transplant,percutaneous nephrolithomy, abdominal surgeries including laparoscopic and open nephrectomy, and nephrectomy in the pediatric population.
The aim of this prospective randomized controlled study is to investigate the efficacy of ESPB for pain control in adult patients undergoing open renal surgery through a flank incision with respect to pain scores, postoperative analgesia consumption and patient satisfaction.
Read the detailed description
This is a prospective randomized controlled study which will be conducted in the Anesthesiology Department at Theodor Bilharz Research Institute after approval by the institutional review board and obtaining patient informed consent. 46 patients will be enrolled in the study and will be randomized to be equally divided into two groups: ESPB group(E group) and control group (C group).
Anesthetic technique:
A preoperative assessment, including a history, physical examination, review of laboratory data, and assignment of ASA classification will be performed on all patients prior to the procedure. After premedication with intravenous midazolam 2 mg, patients will be transferred to the operating room.
Standard monitors such as noninvasive blood pressure, electrocardiography (ECG), and pulse oximetry (SpO2) will be attached. Anesthesia will be induced using propofol 1-2 mg/kg, fentanyl 1-2 µg/kg and sevoflurane. After adequate manual ventilation, atracurium 0.5 mg/kg will be administered to facilitate endotracheal intubation. Ventilation will be started with oxygen and medical air (FiO2 = 0.6). Patients will be positioned in the lateral position to perform the ESPB and for preparation for surgery.
Erector SpinaePlane Block technique:
After skin sterilization and draping, a high-frequency linear array ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T7 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius and erector spinae muscle.The rhomboid major muscle has its lower border a tthe T5-6 vertebral level and its absence will be used as additional confirmation that the T7 transverse process is being viewed. An echogenic 22-G block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T7 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will confirmed by injecting 0.5-1 ml normal saline and seeing the fluid lifting the erector spinae muscle off the transverse process without distending the muscle.
ESPB group:
A total of 25 ml bupivacaine 0.5% will be injected into the ESP.
Control group:
The ESPB will not be performed. Surgical technique and postoperative care will follow standard local clinical practice.
Pain management:
Numerical Rating Scale (NRS) pain score will be used immediately postoperatively and then at 30 minutes, 1, 2, 4, 6, 12 and 24 h. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain. Rescue analgesia with intravenous pethidine (25 mg) will be prescribed if the patient's resting NRS score is more than three or on patient demand. Additional intravenous doses of 25 mg of pethidine will be given if needed to achieve a score below 4. The second rescue analgesic plan will be intravenous ketorolac 30 mg diluted in 100 ml normal saline and administered slowly, if NRS remained persistently >3 after 15 min of the first rescue analgesic administration.
Data collection
- Age
- Sex
- BMI
- ASA Classification
- Intraoperative and postoperative arterial blood pressure
- Intraoperative and postoperativeheart rate
- Numerical Rating Scale (NRS) pain score immediately postoperatively and then at 30 minutes, 1, 2, 4, 6, 12 and 24 h.
- Postoperative analgesia consumption
- The overall degree of patient satisfaction will be assessed using a three-point scale (good, moderate, and bad) on the first postoperative day.
- Block related complications (e.g Pneumothorax)
- Postoperative opioid related complications (e.g. Nausea, vomiting, constipation, sedation)
Statistics:
The patients will be randomly divided into two groups; group (E) and group (C). Forty-six patients will be prospectively enrolled for each study of patients who had been diagnosed to be able to reject the null hypothesis that the population means of the groups are equal with Power calculations suggested that a minimum of 23 subjects per group will be required to detect 10% difference in time for first rescue analgesia between groups (taking type I or α error of 5%, type II or β error of 20% and Standard Deviation=10). To be on a safer side, patients will be included in each group (n=23).
Statistical analyses will be performed using JMP ver. 12.0 (SAS Institute Inc., Cary, NC, USA). The number of patients who will be reported complications corresponding percentage (%) for nominal variables; for continuous variables with normal distribution, and the Mann-Whitney U test will be used for nonparametric variables. The level of significance for both the tests set at p<0.05.
- Conditions
- Post Operative Pain
- Being tested
- ESPB block, control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPB blockDrug
A total of 25 ml bupivacaine 0.5% will be injected into the ESP.
controlOther
no ESPB will be given.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Active comparator | A total of 25 ml bupivacaine 0.5% willbe injected into the ESP. Receives: Drug: ESPB block |
| Control group | Placebo comparator | The ESPB will not be performed. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Rescue analgesia with intravenous pethidine (25 mg) will be prescribed if the patient's resting NRS score is more than three or on patient demand. Additional intravenous doses of 25 mg of pethidine will be given if needed to achieve a score below 4. The second rescue analgesic plan will be intravenous ketorolac 30 mg diluted in 100 ml normal saline and administered slowly, if NRS remained persistently >3 after 15 min of the first rescue analgesic administration.
Measured: 30-45 minutes.
Secondary outcomes (2)
Postoperative analgesic consumption
amount of total analgesics required post operatively.
Measured: over the first 24 hours post operatively.
Patient satisfaction
measuring degree of patient discomfort and amount of analgesics required.
Measured: over first 24 hours post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start25 Oct 2019
- Primary completion10 Dec 2020
- Study completion15 Feb 2021
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After skin sterilization and draping, a high-frequency linear array ultrasound probe will be placed on the back in a transversly to identify the tip of the T7 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be rotated into a longitudinally to produce a para-sagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius and erector spinae muscle. An echogenic 22-G block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T7 transverse process. Correct location oft he needle tip in the fascial plane deep to erector spinae muscle will confirmed by injecting 0.5-1 ml normal saline and seeing the fluid lifting the erector spinae muscle off the transverse process without distending the muscle.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
- Investigators
- Moshira S Mohamed, MD, Principal investigator, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118101
- Sponsor's protocol ID
- TBRI 2
- Status last verified
- Apr 2021
- First submitted
- 4 Oct 2019
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available as excel sheets supplemented with the results but other personal data won't be available to ensure patient privacy.
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Patients Undergoing Open Renal Surgery Through Flank Incision: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04118101
- Acronym / sponsor ID
- TBRI 2
- Conditions
- Post Operative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 8 Oct 2019 (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.
Erector spinae plane block (ESPB) is a relatively new plane block that was first described by Forero et al. in 2016, to manage persistent neuropathic pain following malunited rib fracture and persistent post-thoracotomy neuropathic pain.It's a relatively simple, ultrasound guided block in which the local anesthetic drugs are injected in the plane between the erector spinae muscle and the vertebral transverse process.This allows the injected local anesthetics to block the ventral and dorsal rami of the spinal nerves in the paravertebral area.
The literature reveals successful case reports denoting the use of ESPB for pain control in cases of acute kidney transplant,percutaneous nephrolithomy, abdominal surgeries including laparoscopic and open nephrectomy, and nephrectomy in the pediatric population.
The aim of this prospective randomized controlled study is to investigate the efficacy of ESPB for pain control in adult patients undergoing open renal surgery through a flank incision with respect to pain scores, postoperative analgesia consumption and patient satisfaction.
Detailed description
This is a prospective randomized controlled study which will be conducted in the Anesthesiology Department at Theodor Bilharz Research Institute after approval by the institutional review board and obtaining patient informed consent. 46 patients will be enrolled in the study and will be randomized to be equally divided into two groups: ESPB group(E group) and control group (C group).
Anesthetic technique:
A preoperative assessment, including a history, physical examination, review of laboratory data, and assignment of ASA classification will be performed on all patients prior to the procedure. After premedication with intravenous midazolam 2 mg, patients will be transferred to the operating room.
Standard monitors such as noninvasive blood pressure, electrocardiography (ECG), and pulse oximetry (SpO2) will be attached. Anesthesia will be induced using propofol 1-2 mg/kg, fentanyl 1-2 µg/kg and sevoflurane. After adequate manual ventilation, atracurium 0.5 mg/kg will be administered to facilitate endotracheal intubation. Ventilation will be started with oxygen and medical air (FiO2 = 0.6). Patients will be positioned in the lateral position to perform the ESPB and for preparation for surgery.
Erector SpinaePlane Block technique:
After skin sterilization and draping, a high-frequency linear array ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T7 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius and erector spinae muscle.The rhomboid major muscle has its lower border a tthe T5-6 vertebral level and its absence will be used as additional confirmation that the T7 transverse process is being viewed. An echogenic 22-G block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T7 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will confirmed by injecting 0.5-1 ml normal saline and seeing the fluid lifting the erector spinae muscle off the transverse process without distending the muscle.
ESPB group:
A total of 25 ml bupivacaine 0.5% will be injected into the ESP.
Control group:
The ESPB will not be performed. Surgical technique and postoperative care will follow standard local clinical practice.
Pain management:
Numerical Rating Scale (NRS) pain score will be used immediately postoperatively and then at 30 minutes, 1, 2, 4, 6, 12 and 24 h. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain. Rescue analgesia with intravenous pethidine (25 mg) will be prescribed if the patient's resting NRS score is more than three or on patient demand. Additional intravenous doses of 25 mg of pethidine will be given if needed to achieve a score below 4. The second rescue analgesic plan will be intravenous ketorolac 30 mg diluted in 100 ml normal saline and administered slowly, if NRS remained persistently >3 after 15 min of the first rescue analgesic administration.
Data collection
- Age
- Sex
- BMI
- ASA Classification
- Intraoperative and postoperative arterial blood pressure
- Intraoperative and postoperativeheart rate
- Numerical Rating Scale (NRS) pain score immediately postoperatively and then at 30 minutes, 1, 2, 4, 6, 12 and 24 h.
- Postoperative analgesia consumption
- The overall degree of patient satisfaction will be assessed using a three-point scale (good, moderate, and bad) on the first postoperative day.
- Block related complications (e.g Pneumothorax)
- Postoperative opioid related complications (e.g. Nausea, vomiting, constipation, sedation)
Statistics:
The patients will be randomly divided into two groups; group (E) and group (C). Forty-six patients will be prospectively enrolled for each study of patients who had been diagnosed to be able to reject the null hypothesis that the population means of the groups are equal with Power calculations suggested that a minimum of 23 subjects per group will be required to detect 10% difference in time for first rescue analgesia between groups (taking type I or α error of 5%, type II or β error of 20% and Standard Deviation=10). To be on a safer side, patients will be included in each group (n=23).
Statistical analyses will be performed using JMP ver. 12.0 (SAS Institute Inc., Cary, NC, USA). The number of patients who will be reported complications corresponding percentage (%) for nominal variables; for continuous variables with normal distribution, and the Mann-Whitney U test will be used for nonparametric variables. The level of significance for both the tests set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After skin sterilization and draping, a high-frequency linear array ultrasound probe will be placed on the back in a transversly to identify the tip of the T7 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be rotated into a longitudinally to produce a para-sagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius and erector spinae muscle. An echogenic 22-G block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T7 transverse process. Correct location oft he needle tip in the fascial plane deep to erector spinae muscle will confirmed by injecting 0.5-1 ml normal saline and seeing the fluid lifting the erector spinae muscle off the transverse process without distending the muscle.
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Active comparator | Drug: ESPB blockA total of 25 ml bupivacaine 0.5% willbe injected into the ESP. |
| Control group | Placebo comparator | Other: controlThe ESPB will not be performed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient is able to provide a written informed consent.
- ASA I-II.
- Patient is scheduled to perform an elective open renal surgery through a flank incision.
Key exclusion criteria (6 listed)
- ASA III-IV
- Pregnancy.
- Patient is allergic to bupivacaine local anesthetic.
- Impaired coagulation (Platelet count< 150,000 cells/mcl and/or INR ≥ 1.4).
- Infection at site of injection.
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 |
|---|---|---|
| ESPB blockA total of 25 ml bupivacaine 0.5% will be injected into the ESP. | Drug | ESPB group |
| controlno ESPB will be given. | Other | Control group |
Primary outcome
Time to first rescue analgesia
Time frame: 30-45 minutes.
Rescue analgesia with intravenous pethidine (25 mg) will be prescribed if the patient's resting NRS score is more than three or on patient demand. Additional intravenous doses of 25 mg of pethidine will be given if needed to achieve a score below 4. The second rescue analgesic plan will be intravenous ketorolac 30 mg diluted in 100 ml normal saline and administered slowly, if NRS remained persistently >3 after 15 min of the first rescue analgesic administration.
2 secondary outcomes
Postoperative analgesic consumption
Time frame: over the first 24 hours post operatively.
Patient satisfaction
Time frame: over first 24 hours post operatively.
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 2 Apr 2021.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Individual participant dataSharing planned: Yes. IPD will be available as excel sheets supplemented with the results but other personal data won't be available to ensure patient privacy.
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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.
Moshira S Mohamed, MD principal investigator
Theodor Bilharz Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ESPB block in people with Post Operative Pain, run by Theodor Bilharz Research Institute 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 6 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 2 Apr 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first rescue analgesia (time frame: 30-45 minutes.). 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 NCT04118101, 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 2 Apr 2021.