Perioperative PainNCT04320212
Lumbar Epidural Analgesia With Bilateral Erector Spinae Block for Pain Management in Lumbar Spine Surgery
A study testing lumber epidural analgesia and erector spinae analgesia in people with Perioperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Surgical procedures on the spine and spinal cord are common and are performed for a wide variety of diseases. They range from minimally invasive, single-level decompression to highly complex, multi-stage extensive reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perioperative Pain
- What is being tested?
- lumber epidural analgesia and erector spinae analgesia
- 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
- 1 Apr 2020to 22 Mar 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I, II patients
- Aged 18-60 years
- Undergoing elective lumbar spine decompression and fusion surgery, using the posterior approach, under general anaesthesia.
Who cannot join
- Patients with severe cardiac diseases as ischemic heart disease, rheumatic valve disorders and cardiomyopathy.
- Contraindication to neuroaxial anaesthesia e.g. patients on anticoagulants, infection at the injection site and coagulopathy
- Hypersensitivity to the local anaesthetics used.
- Patient refusal.
- Neurologic deficits in the form of sensory loss, motor weakness or preexisting pain symptoms due to neurologic diseases apart from back pain associated with the planned operation.
- Patients with previous back surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparative Trial of Pre-surgical Lumbar Epidural Analgesia With Bilateral Erector Spinae Block for Perioperative Pain Management in Lumbar Spine Surgery
Surgical procedures on the spine and spinal cord are common and are performed for a wide variety of diseases. They range from minimally invasive, single-level decompression to highly complex, multi-stage extensive reconstruction. Operative procedures for degenerative spine diseases and herniated discs are most common in those under 60 years of age. While those over 60 years of age most commonly undergo spine surgery for spinal stenosis
Patients undergoing spine surgery experience severe pain in the postoperative period. Recent studies show that the incidence of acute postoperative pain following spine surgery vary from 30 to 64%. Postoperative pain may also increase morbidity and incidence of complications and prolong postoperative rehabilitation. In addition, it is a risk factor for development of chronic pain syndromes
Read more
Postoperative pain is usually treated with oral or intravenous opioids in combination with non-steroidal anti-inflammatory drugs. However, they often results in insufficient pain control and side effects such as respiratory depression, nausea, and vomiting.
Epidural anaesthesia and analgesia have been shown to be superior to intravenous analgesia. The former is better with respect to pain quality, incidence of side effects, pulmonary, cardiac, and gastrointestinal dysfunction. However, it may be associated with hemodynamic instability. Migration of the epidural catheter with unpredictable absorption of the local anaesthetics remains a challenge to the anaesthetists. The Erector Spinae block proved to be efficient in controlling post-operative pain. It is a simple interfascial plane block, published in 2016. It provides effective analgesia for 24 hours in patients undergoing lumbar spine surgery.
Therefore, a prospective, randomized study was designed to compare the analgesic and side effects of the epidural analgesia with the Erector Spinae block in patients undergoing lumbar spine surgery. To our knowledge, this is the first clinical trial that compares the Erector Spinae block with the epidural analgesia in a variety of lumbar spine surgeries.
Read the detailed description
History will be taken from all patients. Age and then American Society of Anaesthesiologists' (ASA) score will be recorded.
Preoperatively patients' pain score, laboratory investigations as complete blood picture, coagulation profile, liver and renal functions will be recorded. General examination will be carried out with examination of the back to exclude infection at the injection site and anatomical deformities.
Baseline vital signs will be recorded including non-invasive measurement of systolic, mean, diastolic arterial pressures, and heart rate and oxygen saturation.
After inserting an intravenous (IV) access, the patient will be pre-medicated with midazolam in a dose 0.1 mg/kg and metoclopramide in a dose 0.1-0.2 mg/kg.
Upon arrival to the operating room, appropriate monitors (continuous pulse oximetry, electrocardiography and non-invasive blood pressure) will be placed. Then, general anaesthesia will be induced. 1.5 μg/kg fentanyl and 2 mg/kg propofol will be given. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium. Anaesthesia will be maintained using isoflurane in oxygen and air. Additional doses of 0.1 mg/kg atracurium will be administrated every 30 minutes. A urinary catheter will be placed for control of diuresis. the patient will receive either lumber epidural or erector spinae analgesia according to the group randomization.
The surgical intervention will be then allowed 20 minutes after finishing the block procedure.
Failed block is defined as increase in heart rate (HR) and mean arterial blood pressure (MABP)>20% from base line with skin incision. This will be treated by 1ug /kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl.
In case of decrease in MABP>20% from base line, the patient will receive a 500 ml ringer infusion with 5 mg ephedrine. If HR decrease to 45 beats/minute, atropine 0.5 mg will be given.
postoperative nausea and vomiting will be managed with 0.1 mg/kg ondansetron
- Conditions
- Perioperative Pain
- Being tested
- lumber epidural analgesia, erector spinae analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumber epidural analgesiaProcedure or surgery
the lumber epidural analgesia will be given after induction of general anesthesia.
erector spinae analgesiaProcedure or surgery
the erector spinae analgesia will be given after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| lumber epidural analgesia | Active comparator | : the patient will be placed in the lateral position, Lidocaine will be given using 5 ml syringe and a 18 G Tuohy needle will be introduced in the epidural space, using the ultrasound, under strict aseptic precautions. The ultrasound probe will be placed 90 degrees into transverse orientation and slided cephalad or caudad to obtain the transverse interspinous view (TI view) 2 levels above the operation level. patient will receive 20 ml of 0.25% plain bupivacaine after negative aspiration for blood or cerebrospinal fluid. Then, the patient will be placed in prone position to start the surgical procedure Receives: Procedure: lumber epidural analgesia |
| erector spinae analgesia | Active comparator | the patient will be placed in the prone position. Then, the Erector Spinae block will be given by a high-frequency linear ultrasound transducer. The Erector Spinae muscle and transverse process will be then identified, and a 18 G Tuohy needle will be advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle. The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) Receives: Procedure: erector spinae analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesic request
minutes
Measured: from the time of performance of the intervention till the first analgesic requirement during the 24 hours postoperative
Secondary outcomes (5)
The numeric rate scale (NRS)
Pain will be classified as mild (NRS 0-4), moderate (NRS 5-7), and severe (NRS 8-10)
Measured: 5 minutes after extubation,1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hour postoperative
postoperative morphine consumption
mg
Measured: 5 minutes after extubation till 24 hour postoperative
postoperative diclofenac consumption
mg
Measured: 5 minutes after extubation till 24 hour postoperative
systolic blood pressure
mmHg
Measured: every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively.
heart rate
beat per minute
Measured: every 10 minutes from skin incision to skin closure and at 2, 4 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 posted24 Mar 2020
- Study start1 Apr 2020
- Primary completion20 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Kamal Zahran, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320212
- Sponsor's protocol ID
- M D-82 -2019
- Status last verified
- Aug 2021
- First submitted
- 19 Dec 2019
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Trial of Pre-surgical Lumbar Epidural Analgesia With Bilateral Erector Spinae Block for Perioperative Pain Management in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT04320212
- Acronym / sponsor ID
- M D-82 -2019
- Conditions
- Perioperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 24 Mar 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.
Surgical procedures on the spine and spinal cord are common and are performed for a wide variety of diseases. They range from minimally invasive, single-level decompression to highly complex, multi-stage extensive reconstruction. Operative procedures for degenerative spine diseases and herniated discs are most common in those under 60 years of age. While those over 60 years of age most commonly undergo spine surgery for spinal stenosis
Patients undergoing spine surgery experience severe pain in the postoperative period. Recent studies show that the incidence of acute postoperative pain following spine surgery vary from 30 to 64%. Postoperative pain may also increase morbidity and incidence of complications and prolong postoperative rehabilitation. In addition, it is a risk factor for development of chronic pain syndromes
Postoperative pain is usually treated with oral or intravenous opioids in combination with non-steroidal anti-inflammatory drugs. However, they often results in insufficient pain control and side effects such as respiratory depression, nausea, and vomiting.
Epidural anaesthesia and analgesia have been shown to be superior to intravenous analgesia. The former is better with respect to pain quality, incidence of side effects, pulmonary, cardiac, and gastrointestinal dysfunction. However, it may be associated with hemodynamic instability. Migration of the epidural catheter with unpredictable absorption of the local anaesthetics remains a challenge to the anaesthetists. The Erector Spinae block proved to be efficient in controlling post-operative pain. It is a simple interfascial plane block, published in 2016. It provides effective analgesia for 24 hours in patients undergoing lumbar spine surgery.
Therefore, a prospective, randomized study was designed to compare the analgesic and side effects of the epidural analgesia with the Erector Spinae block in patients undergoing lumbar spine surgery. To our knowledge, this is the first clinical trial that compares the Erector Spinae block with the epidural analgesia in a variety of lumbar spine surgeries.
Detailed description
History will be taken from all patients. Age and then American Society of Anaesthesiologists' (ASA) score will be recorded.
Preoperatively patients' pain score, laboratory investigations as complete blood picture, coagulation profile, liver and renal functions will be recorded. General examination will be carried out with examination of the back to exclude infection at the injection site and anatomical deformities.
Baseline vital signs will be recorded including non-invasive measurement of systolic, mean, diastolic arterial pressures, and heart rate and oxygen saturation.
After inserting an intravenous (IV) access, the patient will be pre-medicated with midazolam in a dose 0.1 mg/kg and metoclopramide in a dose 0.1-0.2 mg/kg.
Upon arrival to the operating room, appropriate monitors (continuous pulse oximetry, electrocardiography and non-invasive blood pressure) will be placed. Then, general anaesthesia will be induced. 1.5 μg/kg fentanyl and 2 mg/kg propofol will be given. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium. Anaesthesia will be maintained using isoflurane in oxygen and air. Additional doses of 0.1 mg/kg atracurium will be administrated every 30 minutes. A urinary catheter will be placed for control of diuresis. the patient will receive either lumber epidural or erector spinae analgesia according to the group randomization.
The surgical intervention will be then allowed 20 minutes after finishing the block procedure.
Failed block is defined as increase in heart rate (HR) and mean arterial blood pressure (MABP)>20% from base line with skin incision. This will be treated by 1ug /kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl.
In case of decrease in MABP>20% from base line, the patient will receive a 500 ml ringer infusion with 5 mg ephedrine. If HR decrease to 45 beats/minute, atropine 0.5 mg will be given.
postoperative nausea and vomiting will be managed with 0.1 mg/kg ondansetron
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumber epidural analgesia | Active comparator | Procedure: lumber epidural analgesia: the patient will be placed in the lateral position, Lidocaine will be given using 5 ml syringe and a 18 G Tuohy needle will be introduced in the epidural space, using the ultrasound, under strict aseptic precautions. The ultrasound probe will be placed 90 degrees into transverse orientation and slided cephalad or caudad to obtain the transverse interspinous view (TI view) 2 levels above the operation level. patient will receive 20 ml of 0.25% plain bupivacaine after negative aspiration for blood or cerebrospinal fluid. Then, the patient will be placed in prone position to start the surgical procedure |
| erector spinae analgesia | Active comparator | Procedure: erector spinae analgesiathe patient will be placed in the prone position. Then, the Erector Spinae block will be given by a high-frequency linear ultrasound transducer. The Erector Spinae muscle and transverse process will be then identified, and a 18 G Tuohy needle will be advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle. The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I, II patients
- Aged 18-60 years
- Undergoing elective lumbar spine decompression and fusion surgery, using the posterior approach, under general anaesthesia.
Key exclusion criteria (6 listed)
- Patients with severe cardiac diseases as ischemic heart disease, rheumatic valve disorders and cardiomyopathy.
- Contraindication to neuroaxial anaesthesia e.g. patients on anticoagulants, infection at the injection site and coagulopathy
- Hypersensitivity to the local anaesthetics used.
- Patient refusal.
- Neurologic deficits in the form of sensory loss, motor weakness or preexisting pain symptoms due to neurologic diseases apart from back pain associated with the planned operation.
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 |
|---|---|---|
| lumber epidural analgesiathe lumber epidural analgesia will be given after induction of general anesthesia. | Procedure or surgery | lumber epidural analgesia |
| erector spinae analgesiathe erector spinae analgesia will be given after induction of general anesthesia. | Procedure or surgery | erector spinae analgesia |
Primary outcome
time to first analgesic request
Time frame: from the time of performance of the intervention till the first analgesic requirement during the 24 hours postoperative
minutes
5 secondary outcomes
The numeric rate scale (NRS)
Time frame: 5 minutes after extubation,1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hour postoperative
postoperative morphine consumption
Time frame: 5 minutes after extubation till 24 hour postoperative
postoperative diclofenac consumption
Time frame: 5 minutes after extubation till 24 hour postoperative
systolic blood pressure
Time frame: every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively.
heart rate
Time frame: every 10 minutes from skin incision to skin closure and at 2, 4 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 16 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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 lumber epidural analgesia and erector spinae analgesia in people with Perioperative Pain, 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 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 16 Aug 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. 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?
time to first analgesic request (time frame: from the time of performance of the intervention till the first analgesic requirement during the 24 hours postoperative). 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 16 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.