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Analgesic EfficacyNCT03504371

The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Oesophageal Surgeries

A study testing bilateral erector spinae block and Thoracic epidural anesthesia in people with Analgesic Efficacy, run by Ain Shams 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

a total of 80 patients age of 36 years old to 65 years old, (ASA) physical status I and II undergoing oesophageal procedures.The patients will randomised using concealed envelope method into 2 groups, allocation of patients to either group will be done by clinician not involved in the study. Read more about this study

Who is it for?
Ages 36 to 65 years
Conditions the study is for
Analgesic Efficacy
What is being tested?
bilateral erector spinae block and Thoracic epidural anesthesia
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteEgypt
Study dates
14 Feb 2018to 2 Apr 2019
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 36 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 36-65 years old oesophageal procedures ASA I,II
  • -

Who cannot join

  • cardiac dysfunction Renal or hepatic impairment patient refusal Immune disorders Allergy to local anesthetics neuromuscular disorders

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams U

    Cairo, 11566

Other trials in Egypt

About this study

Official title: The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Patients Having Transthoracic Oesophygeal Surgical Procedures

a total of 80 patients age of 36 years old to 65 years old, (ASA) physical status I and II undergoing oesophageal procedures.The patients will randomised using concealed envelope method into 2 groups, allocation of patients to either group will be done by clinician not involved in the study. There are 2 groups of patients: TEA combined with GA (TEA group) or bilateral erector spinae block combined with GA (erector group). . In TEA group, patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%. Anaesthesia will be standardised In the TEA group, an additional 4-5mL epidural doses of bupivacaine 0.25% will be administered at 1 h intervals. In the second group, patients will receive bilateral ESP block which will be performed as follows. The patient will be placed in a lateral position ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. A total of 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way without changing the position of the patient to achieve sensory block T5-T10 .

Read the detailed description

The patients will randomised into 2 groups. There are 2 groups of patients: TEA combined with GA or bilateral erector spinae block combined with G. In TEA group, patients will receive TEA, an epidural catheter will be placed at the T7-8 interspace after positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%. Anaesthesia will be standardised. A left-sided, double-lumen thoracostomy tube will be inserted and confirmed by bronchofiberoscopy. In the TEA group, an additional 4-5mL epidural doses of bupivacaine 0.25% will be administered at 1 h intervals. In the second group, patients will receive bilateral ESP block which will be performed as follows. The patient will be placed in a lateral position and a high-frequency linear ultrasound transducer (GE LOGIQe, Wauwatosa, Wisconsin) will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle (EchoStim; Benlan Inc, Oakville, Canada) will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. A total of 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way without changing the position of the patient to achieve sensory block T5-T10 .

Hemodynamics as heart rate, arterial blood pressure, central venous pressure and oxygen saturation will be monitored intraoperatively. The heart rate and arterial blood pressure will be maintained within 20% of the preoperative values.

At the end of the procedure, in both groups, anesthesia will be discontinued and neuromuscular blockade will be antagonized with neostigmine, intravenous (0.05 mg/kg) and atropine intravenous (0.03 mg/kg) at appropriate doses.

The patients will be transported postoperatively to the intensive care unit. if VAS > 5 , Patient-controlled analgesia using elastomeric pump will be established with IV doses of morphine in the erector group (basal rate about 0.5mg/h to 1 mg/h and bolus dose of 2 mg , 300 mL maximum dose) and epidural analgesia in the TEA group (top up doses of about 4 ml of bupivacaine 0.125% + morphine 20 μg/mL, bolus doses 2 mL to 3 mL, 300 ml maximum dose). The patients will be monitored in the postanaesthesia care unit (PACU)

Being tested
bilateral erector spinae block, Thoracic epidural anesthesia
Keywords
oesophageal surgeries-epidural-erector block

What participants receive

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

  • bilateral erector spinae blockDevice

    The patient placed in a lateral position and transducer placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way to achieve sensory block T5-T10 .

  • Thoracic epidural anesthesiaDevice

    patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%.

Study groups in NCT03504371
Study groupRoleWhat they receive
bilateral erector spinae blockActive comparatorThe patient placed in a lateral position and ultrasound transducer placed 3 cm lateral to the T7 spinous process. Three muscles will be identified: trapezius, rhomboid major, and erector spinae. 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony shadows of the transverse processes. 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side in the same way without changing the position of the patient to achieve sensory block T5-T10 .
Receives: Device: bilateral erector spinae block
Thoracic epidural anesthesiaSham comparatoran epidural catheter placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine will be injected followed by 5-6 ml of bupivacaine 0.25%
Receives: Device: Thoracic epidural anesthesia

What is being measured

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

  1. postoperative complications

    minor complications (hypotension, vomiting, urinary retention and catheter related complications) and major complications (mortality).

    Measured: 24 h

Secondary outcomes (1)
  1. length of hospital stay

    Recovery time from end of surgery till discharge from hospital

    Measured: 15-17 days

Timeline

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

  1. First posted20 Apr 2018
  2. Study start14 Feb 2018
  3. Primary completion1 Apr 2019
  4. Study completion2 Apr 2019

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504371
Sponsor's protocol ID
FMASU R19
Status last verified
Apr 2018
First submitted
12 Apr 2018
Last updated
4 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study protocol statistical analysis

Questions about this trial

What is this clinical trial studying?

A study testing bilateral erector spinae block and Thoracic epidural anesthesia in people with Analgesic Efficacy, run by Ain Shams 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 2 inclusion and 1 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 4 Apr 2019. 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.

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 complications (time frame: 24 h). 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 4 Apr 2019.

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