Postoperative PainNCT05570565
Erector Spinae Block Versus Local Field Block in Lumbar Spine Surgeries
A study testing Erector spinae plane block and local field block in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector spinae plane block and local field block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2023to Feb 2024
- 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
- Patients 18-65 years old.
- Patients undergoing Lumbar spine surgery (L1-L5).
- American society of anesthesiologists classification (ASA) I and II.
- BMI < 35
- Duration of surgery less than 3 hours
Who cannot join
- Patient's refusal.
- Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%) and coagulopathies.
- Skin lesion, wounds or infection at the injection site.
- Known allergy to local anesthetic drugs.
- Chronic opioid users.
- Patients with pre-operative opioid consumption.
- Patients on long term therapy of Corticosteroids
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university hospitals
Cairo
abdelmoneim A abdelmoneim, lecturer, o1oo4392046 ext. 002, Abdelmoneim_Adel@kasralainy.edu.eg
About this study
Official title: Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Preincisional Local Field Block for Perioperative Analgesia in Lumbar Spine Surgeries; Randomized Controlled Study
Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine surgeries than preincisional local field block.
Read the detailed description
Patients scheduled for lumbar spine surgery will be recruited and a written informed consent will be obtained from patients.
All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT\& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests .
● Operating Room preparation \& Equipment: The ultrasound used will be curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound)
- Methods: General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight.
Volume controlled ventilation will be adjusted to maintain normocapnia . Anesthesia will be maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
Patients will be placed in the prone position on a Relton Hall frame or padded bolsters.
- In group (A): local field block For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach.
- In group (B): Bilateral Ultrasound guided Erector spinae group. The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side.
The surgical intervention will be then allowed 20 minutes after finishing the block procedure.
All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm every 24 hour, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.
Failed block (increase in HR and mean arterial blood pressure (MABP)>20% from base line with skin incision) will be treated by 0.5 ug/kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl.
After skin closure , the patient will be turned to supine position,then inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered intravenous after return of patient's spontaneous breathing .the patient will be extubated awake, Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring.
- At any time hypotension (defined as a decrease in mean arterial pressure (MAP) >25% from baseline value or systolic arterial pressure (SAP <100 mmHg)) will be treated with 5 mg IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved. Bradycardia (HR <50 beats per minute) will be treated with atropine 0.5 mg IV.
- Rescue analgesia :
Intra operative:
0.5ug /kg of fentanyl as top-up doses at any time if blood pressure and heart rate increased by more than 20% from baseline reading .
Post-operative :
In the PACU ; VAS will be assessed 15 minutes after extubation and if the score is exceeding 4/10 , rescue analgesia in the form of Nalbuphine 0.1mg/kg will be given .another dose of Nalbuphine 0.1mg/kg can be given in the PACU if the score still more than 4 after 30 minutes of the 1st dose.
After discharging from the PACU; the analgesic plan will be intravenous paracetamol 1gm every 8hours and ketorolac 0.5mg/kg/6hours as a standard regimen , Nalbuphine 0.1mg/kg will be given as rescue analgesia on demand or at any time if VAS score exceeding 4(maximum 20mg per dose and 160mg in 24 hours)
- Conditions
- Postoperative Pain
- Being tested
- Erector spinae plane block, local field block
- Keywords
- postoperative pain, Erector spinae plane block, lumbar spine surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
ultrasound guided injection of local anesthestics drugs (mixture of lidocaine and bupivacaine) in the Erector spinae plane which lies between the Erector spinae muscle and lumbar transverse process
local field blockProcedure or surgery
infiltration of local anesthestic drugs( mixture of lidocaine and bupivacaine) in the surgical field before surgical incision
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane group | Experimental | The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side.
The surgical intervention will be then allowed 20 minutes after finishing the block procedure Receives: Procedure: Erector spinae plane block |
| local field block | Active comparator | For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach. Receives: Procedure: local field block |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postoperative analgesia
Time to first analgesic request
Measured: 24 hours
Secondary outcomes (5)
cumulative 24 hour opioid consumption
the amount of Nalbuphine consumed by the patient in the first 24 hours postoperative
Measured: 24 hours
pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative
The visual analog scale(VAS) score is a validated,subjective measure for acute and chronic pain, scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and"worst pain".
Measured: 24 hours
presence of any complications
bradycardia,hypotension, arrythmia
Measured: evey 10 minutes intraoperative till end of surgery (up to 2 hours)
patient satisfaction with anesthesia
11 point score , where 0=unsatisfied and 10=most satisfied
Measured: 24 hours
surgeon satisfaction for surgical field accessibility
likert 5 point scale, where 1=very unsatisfied and 5=vry satisfied
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start10 Nov 2023
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd elmoneim Adel Abd elmoneim, Cairo University
- Investigators
- Abdelmoneim A Abdelmoneim, lecturer, Principal investigator, Anesthesia department , cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570565
- Sponsor's protocol ID
- N-40-2022
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Preincisional Local Field Block for Perioperative Analgesia in Lumbar Spine Surgeries; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05570565
- Acronym / sponsor ID
- N-40-2022
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, Erector spinae plane block, lumbar spine surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 6 Oct 2022 (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.
Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine surgeries than preincisional local field block.
Detailed description
Patients scheduled for lumbar spine surgery will be recruited and a written informed consent will be obtained from patients.
All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT\& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests .
● Operating Room preparation \& Equipment: The ultrasound used will be curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound)
- Methods: General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight.
Volume controlled ventilation will be adjusted to maintain normocapnia . Anesthesia will be maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
Patients will be placed in the prone position on a Relton Hall frame or padded bolsters.
- In group (A): local field block For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach.
- In group (B): Bilateral Ultrasound guided Erector spinae group. The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side.
The surgical intervention will be then allowed 20 minutes after finishing the block procedure.
All participants will be given 1 gram of intravenous paracetamol with maximum dose of 4 gm every 24 hour, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.
Failed block (increase in HR and mean arterial blood pressure (MABP)>20% from base line with skin incision) will be treated by 0.5 ug/kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl.
After skin closure , the patient will be turned to supine position,then inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered intravenous after return of patient's spontaneous breathing .the patient will be extubated awake, Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring.
- At any time hypotension (defined as a decrease in mean arterial pressure (MAP) >25% from baseline value or systolic arterial pressure (SAP <100 mmHg)) will be treated with 5 mg IV bolus ephedrine and repeated every 3 minutes until the hypotension resolved. Bradycardia (HR <50 beats per minute) will be treated with atropine 0.5 mg IV.
- Rescue analgesia :
Intra operative:
0.5ug /kg of fentanyl as top-up doses at any time if blood pressure and heart rate increased by more than 20% from baseline reading .
Post-operative :
In the PACU ; VAS will be assessed 15 minutes after extubation and if the score is exceeding 4/10 , rescue analgesia in the form of Nalbuphine 0.1mg/kg will be given .another dose of Nalbuphine 0.1mg/kg can be given in the PACU if the score still more than 4 after 30 minutes of the 1st dose.
After discharging from the PACU; the analgesic plan will be intravenous paracetamol 1gm every 8hours and ketorolac 0.5mg/kg/6hours as a standard regimen , Nalbuphine 0.1mg/kg will be given as rescue analgesia on demand or at any time if VAS score exceeding 4(maximum 20mg per dose and 160mg in 24 hours)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane group | Experimental | Procedure: Erector spinae plane blockThe patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side. The surgical intervention will be then allowed 20 minutes after finishing the block procedure |
| local field block | Active comparator | Procedure: local field blockFor the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18-65 years old.
- Patients undergoing Lumbar spine surgery (L1-L5).
- American society of anesthesiologists classification (ASA) I and II.
- BMI < 35
- Duration of surgery less than 3 hours
Key exclusion criteria (7 listed)
- Patient's refusal.
- Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%) and coagulopathies.
- Skin lesion, wounds or infection at the injection site.
- Known allergy to local anesthetic drugs.
- Chronic opioid users.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane blockultrasound guided injection of local anesthestics drugs (mixture of lidocaine and bupivacaine) in the Erector spinae plane which lies between the Erector spinae muscle and lumbar transverse process | Procedure or surgery | Erector spinae plane group |
| local field blockinfiltration of local anesthestic drugs( mixture of lidocaine and bupivacaine) in the surgical field before surgical incision | Procedure or surgery | local field block |
Primary outcome
duration of postoperative analgesia
Time frame: 24 hours
Time to first analgesic request
5 secondary outcomes
cumulative 24 hour opioid consumption
Time frame: 24 hours
pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative
Time frame: 24 hours
presence of any complications
Time frame: evey 10 minutes intraoperative till end of surgery (up to 2 hours)
patient satisfaction with anesthesia
Time frame: 24 hours
surgeon satisfaction for surgical field accessibility
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Abdelmoneim A Abdelmoneim, lecturer principal investigator
Anesthesia department , cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and local field block in people with Postoperative 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 5 inclusion and 7 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelmoneim A Abdelmoneim, lecturer (01004392046 ext. 202, abdelmoneim_adel@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of postoperative analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.