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Postoperative Pain ManagementNCT04371341

A Comparative Study Between Different Volumes During Erector Spinae Block for Pain Control

A study testing erector spinae block by 0.25% bupivacaine in people with Postoperative Pain Management, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Since its first description by Forero et al. there have been many articles and case reports including an increasingly number of indications for the ESP block: chronic and acute pain treatment, rib fractures management in the emergency setting, treatment of abdominal surgical pain, hip arthroplasty , analgesic… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain Management
What is being tested?
erector spinae block by 0.25% bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
12 May 2020to 3 Jul 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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female patients aged 18-50 years with ASA I-II undergoing open simple nephrectomy operation.

Who cannot join

  • Cardiovascular disease.
  • Cerebrovascular insufficiency.
  • Coagulation defects.
  • hepatic insufficiency.
  • Hypersensitivity to the study drugs.
  • Pregnant patient. And patients receiving vasoactive drugs or beta blockers.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • anesthesia department at Cairo University

    Cairo, Elmanial, 11562

Other trials in Egypt

About this study

Official title: A Comparative Study Between Different Local Anesthetic Volumes Injected During Erector Spinae Block to Reduce Postoperative Opioid Consumption in Patients Undergoing Open Simple Nephrectomy Operations; a Randomized Controlled Trial

Since its first description by Forero et al. there have been many articles and case reports including an increasingly number of indications for the ESP block: chronic and acute pain treatment, rib fractures management in the emergency setting, treatment of abdominal surgical pain, hip arthroplasty , analgesic management in breast surgery,or in spinal surgery.Although ESP block successfully reduced postoperative opioid consumption in clinical reports, no studies thus have investigated the optimum volume of bupivacaine for ESP block as regard a review of the medical literature on December 27th, 2017 that searched terms in 14 articles clearly stated the volume of the bolus and the spread of the anesthetic after an injection of LA, the volume needed to cover one dermatome widely varies from 2.5 mL to 6.6 mL, with a median value of 3.4 mL. Furthermore, the maximum number of dermatomes reached by a single bolus in ESP was of 9 dermatomes after a 30 mL bolus.

Thus, in this study, the investigators evaluate the effect of ESP block which will be performed by using three different volumes (2.5, 3.4 ,6.6 ml/segment) of bupivacaine with the same concentration ,technique ,site of injection and operation.

Read the detailed description

INTRODUCTION In recent years a number of important fascial plane blocks have been described blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdome].The advantage common to all of these blocks is that they are technically easier to perform with lower risk for serious complications.Since its first description by Forero et al. there have been many articles and case reports including an increasingly number of indications for the ESP block: chronic and acute pain treatment , rib fractures management in the emergency setting , treatment of abdominal surgical pain , hip arthroplasty , analgesic management in breast surgery ,or in spinal surgery.The ESP block targets the erector spinae plane, which lies in the chest wall between the anterior surface of the cephalo caudal oriented erector spinae muscles and the posterior surface of the spinal transverse processes. LA is deposited in the fascial plane deep to the erector spinae muscle and superficial to the tips of the transverse processes, from where it diffuses to the dorsal and ventral rami of spinal nerves, achieving an extensive multi-dermatomal sensory block of the posterior, lateral, and anterior thoracic wall .Chin et al reported that an injection of 20 ml into the ESP produces clinical and radiographic evidence of spread that extends at least three vertebral levels cranially and four levels caudally from the site of injection.A study with magnetic resonance imaging demonstrated and confirmed that its mechanism of action is likely linked to the transforaminal and epidural spread, which may be a potential advantage because the ESP block provides abdominal visceral analgesia unlike the others .beside its ability to spread to paravertebral and intervertebral spaces and ability to block the sympathetic nerve fibers. the ESP block is considered as a peri-paravertebral regional anesthesia technique.LAs, is injectted with volumes ranging from 20 mL to 40 mL, and concentrations ranging from 0.25%-0.5%.even though a higher LA concentration might allow for better diffusion into the paravertebral space .

Open surgery remains common for patients requiring radical or partial nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain in the months following surgery. ESP block was for open partial nephrectomy with excellent results both in the intraoperative and postoperative period, with a large reduction in the use of opioids.

Although ESP block successfully reduced postoperative opioid consumption in clinical reports, no studies thus have investigated the optimum volume of bupivacaine for ESP block as regard a review of the medical literature on December 27th, 2017 that searched terms in 14 articles clearly stated the volume of the bolus and the spread of the anesthetic after an injection of LA, the volume needed to cover one dermatome widely varies from 2.5 mL to 6.6 mL, with a median value of 3.4 mL. Furthermore, the maximum number of dermatomes reached by a single bolus in ESP was of 9 dermatomes after a 30 mL bolus.

Thus, in this study, the investigators evaluate the effect of ESP block which will be performed by using three different volumes (2.5, 3.4 ,6.6 ml/segment) of bupivacaine with the same concentration ,technique ,site of injection and operation.

Methodology:

Eighty Patients, aging from 18-50 years with ASA physical status I and II, undergoing open simple nephrectomy will be included and randomly distributed into 4 groups with 20 patients for each group where group C will not receive erector spinae block and so will be the control group while groups which will receive erector spinae block will be E1,E2,E3 and will receive 0.25% bupivacaine with volumes of 2.5,3.4,6.6 ml/segment respectively.

The day before surgery, all patients will be instructed to fast for 6-8 hours. On the day of the operation,the patient will arrive to the preparation room 1 hour before operation,to allow time for the block procedure and a minimum of 45 minutes after the block to pass, an 18 G cannula insertion, a start of IV fluid drip, and premedication with 0.02-0.03 mg/kg intravenous midazolam will be done. All basic monitoring will be applied (ECG/HR/SpO2/NIBP), and baseline values for HR, SPO2 ,SBP,DBP and MAP will be documented then every 5 minutes till the patient reaches the operating room.

A mark will be applied on the required level (T8), the midline (spinous processes) and the injection points 3 cm from midline.While the patient is in a sitting position with support from a member of staff, Preparation of the field with iodine will be made. Using ultrasound guidance with a 6-10 MHz linear probe anatomical landmarks will be identified including the transverse process at T8 level and the three layers of muscles from posterior to anterior: trapezius-rhomboid-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal needle will be inserted under ultrasound guidance in plane, aiming towards the transverse process. After a Gentle contact with the transverse process, the volume of 0.25% bupivacaine will be injected according to each group 2.5, 3.4 ,6.6 ml/segment in increments with careful repetitive aspiration to avoid intravascular injection.

Spread of the local anesthetic will be monitored by U/S anterior to erector spinae muscles (dividing erector spinae muscles from transverse process with caudal and cephalic spread) then the end point of local anesthetic will be marked and the corresponding covered level will be assessed caudal and cephalic from T8.onset of the block will be tested by pin brick test every 10 minutes after performing the block maximum 30 minutes otherwise it will be considered failed block and documented for each group while dermatomal spread will be assessed by pin brick test 30 minutes after onset of the block and will be documented.

Then the patient will be transferred to the OR. All basic monitoring will be applied (ECG/HR/SpO2/NIBP) while monitoring of end-tidal CO2, neuromuscular block and depth of anesthesia using Bispectral index (BIS) monitor will be initiated after induction of anesthesia and values will be recorded for HR, SPO2 ,SBP,DBP ,MAP and ETCO2 every 5 minutes till the end of the surgery then for 30 minutes from time of reaching PACU.

General anesthesia will be inducted with 2 mg/kg propofol, 1μg/kg fentanyl and 0.5 mg/kg atracurium to facilitate endotracheal intubation. After intubation the lungs will be mechanically ventilated to maintain the ETCO2 35-40 mmHg. Then Patient positioned in the lateral position. Anesthesia will be maintained with isoflurane keeping the ET concentration of isoflurane 1-2% to maintain the BIS value 40-60. Atracurium besylate top-up doses 0.1mg/kg will be given based on the response to train of four ulnar nerve stimulation. Additional fentanyl dose of 0.5 µg/kg IV for maximum of 2 µg/kg will be given if HR and or BP increased more than 20% from baseline in response to surgical stimulation and the total dose of fentanyl will be recorded.

The patient's pain will be monitored and documented using the Numerical Rating Score (NRS) for pain at times 0,30 minutes, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours. The "zero" point of time will be the moment the patient recovered from general anesthesia. Time to first analgesic requirement will be recorded. Rescue medication for pain will be given on demand including 1 g paracetamol IV when NRS >/= 2 but < 4 and if NRS is 4 or more a 5 mg morphine IV with maximum dose of 10 mg every 6 hours and the total consumption of these medications will be recorded.

Being tested
erector spinae block by 0.25% bupivacaine
Keywords
erector spinae, -block, volume, pain
Medical subject headings
Bites and Stings, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae block by 0.25% bupivacaineProcedure or surgery

    Also called erector spinae plane block

    A mark will be applied on the required level (T8), the midline (spinous processes) and the injection points 3 cm from midline.While the patient is in a sitting position with support from a member of staff, Preparation of the field with iodine will be made. Using ultrasound guidance with a 6-10 MHz linear probe anatomical landmarks will be identified including the transverse process at T8 level and the three layers of muscles from posterior to anterior: trapezius-rhomboid-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal needle will be inserted under ultrasound guidance in plane, aiming towards the transverse process. After a Gentle contact with the transverse process, 0.25% bupivacaine is injected in increments with careful repetitive aspiration to avoid intravascular injection.

Study groups in NCT04371341
Study groupRoleWhat they receive
E1Experimentalwill receive erector spinae block with 0.25% bupivacaine volume of 2.5 ml/segment
Receives: Procedure: erector spinae block by 0.25% bupivacaine
E2Experimentalwill receive erector spinae block 0.25% bupivacaine with volume of 3.4ml/segment
Receives: Procedure: erector spinae block by 0.25% bupivacaine
E3Experimentalwill erector spinae block receive 0.25% bupivacaine with volume of 6.6 ml/segment
Receives: Procedure: erector spinae block by 0.25% bupivacaine
CNo interventionwill not receive erector spinae block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative morphine consumption in milligrams in the three groups

    if NRS is 4 or more a 5 mg morphine IV with maximum dose of 10 mg every 6 hours will be given and the total consumption of these medications will be recorded.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start12 May 2020
  3. Primary completion1 Jul 2021
  4. Study completion3 Jul 2021

Resources

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
Model description
4 groups with 20 patients for each group where group C will not receive erector spinae block and so will be the control group while groups which will receive erector spinae block will be E1,E2,E3 and will receive 0.25% bupivacaine with volumes of 2.5,3.4,6.6 ml/segment respectively.
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371341
Sponsor's protocol ID
_MD-248-2019
Status last verified
Jul 2021
First submitted
28 Apr 2020
Last updated
28 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: introduction and methodology are to be shared

Publications

  • 1. 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 ;41(5):621-7. 2. Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth 2017;118(3):474-5 3. Josh Luftig P, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. The authors reply to the optimal dose and volume of local anesthetic for erector spinae plane blockade for posterior rib fractures. Am J Emerg Med 2018;36(6):1103-4 4. Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia 2017;7(4):452-60 5. Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth 2018;47:5-6

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae block by 0.25% bupivacaine in people with Postoperative Pain Management, 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 1 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 28 Jul 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?

postoperative morphine consumption in milligrams in the three groups (time frame: 24 hours). 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 NCT04371341, 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 28 Jul 2021.

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