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Acute Postoperative PainNCT05351203

Ultrasound Guided Bilateral Erector Spinae Block Versus Caudal in Lumbar Spine Surgeries

A study testing caudal block and Erector spinae block in people with Acute Postoperative Pain, 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

Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Acute Postoperative Pain
What is being tested?
caudal block and Erector spinae block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
8 May 2022to 22 May 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing Lumbar spine surgery (L1-L5).
  • American society of anesthesiologists classification (ASA) I and II.

Who cannot join

  • Patient's refusal.
  • Bleeding disorders (platelets count < 150,000; International normalized ratio >1.5; PC< 60%) and coagulopathies.
  • Skin lesion, wounds or infection at the injection site.
  • Known allergy to local anesthetic drugs.
  • Chronic opioid or NSAIDS users.
  • Patients with pre-operative opioid consumption

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy Hospitals

    Giza, Cairo Governorate, 11562

Other trials in Egypt

About this study

Official title: Ultrasound Guide Bilateral Erector Spinae Block Versus Caudal Epidural Analgesia for Perioperative Analgesia in Lumbar Spine Surgeries:Randomized Controlled Study

Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) as a new technique of trunk fascia block was proposed in 2016Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.

The aim of this work is to evaluate the pre-emptive analgesic effect of Ultrasound guided bilateral erector spinae block Vs Caudal epidural analgesia in Lumbar spine surgeries during peri-operative period.

Read more

Objectives:

  • To assess the duration of analgesia in both groups and time to rescue analgesia .
  • To assess Visual analogue scale (VAS) score in both groups.
  • To assess complications of both groups
Read the detailed description

This is a randomized controlled study designed to include 50 patients aged from 18 to 65 years old undergoing lumbar spine surgeries.

fifty patients meeting the inclusion criteria will be randomly assigned into two equal groups: Group A(n=25): caudal epidural group. Group B(n=25): bilateral ultrasound guided Erector spinae block group.

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 SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 MHz linear array).

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. (14) Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight. (15) . The surgical intervention will be then allowed 20 minutes after finishing the block procedure.

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.

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 Heart rate (HR) and mean arterial blood pressure (MABP)>20% from base line with skin incision) will be treated by 1 ug/kg of fentanyl as top-up doses and increasing isoflurane concentration in case of inadequate response to fentanyl.

After skin closure, 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. 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 (defined as a HR <40 beats per minute) will be treated with atropine 0.5 mg IV.
  • In group (A): Caudal Epidural Analgesia
  • For the caudal block, the patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock by betadine three times and will be covered by sterile drapes exposing the sacral area. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound transducer that is covered in sterile plastic bag . Short axis (transverse) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.
  • 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, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.
  • 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 : Nalbuphine (0.1 mg/kg) will be given if the pain score > 4/10 at the VAS assessment times or when the patient asks for supplementary analgesia due to an emerging pain in between the assessment points.

Being tested
caudal block, Erector spinae block
Keywords
caudal, Erector spinae block, lumbar 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.

  • caudal blockProcedure or surgery

    Also called caudal epidural block

    . Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound,. Short axis (transverse) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.

  • Erector spinae blockProcedure or surgery

    Also called ESP block

    ● 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 (Siemens acuson x300 3-5 MHz ultrasound) 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, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.

Study groups in NCT05351203
Study groupRoleWhat they receive
caudal epidural groupActive comparatorthe patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock by betadine three times and will be covered by sterile drapes exposing the sacral area. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound linear transducer probe that is covered in sterile plastic bag . Short axis (transverse) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.
Receives: Procedure: caudal block
Erector spinae groupExperimental● 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 (Siemens acuson x300 3-5 MHz ultrasound) 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, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.
Receives: Procedure: Erector spinae block

What is being measured

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

  1. time to first analgesia request

    postoperative first rescue analgesia time

    Measured: 12 hours

Secondary outcomes (5)
  1. cumulative 24 hours opioid consumption

    the total amount of opioid consumed by the patient in the first 24 hours postoperative

    Measured: 24 hours

  2. presence of any complications

    presence of any complications such as urine retention,vomiting ,respiratory depression

    Measured: 24 hours

  3. Mean arterial blood pressure

    intraoperative mean arterial blood pressure

    Measured: evey 10 minutes intraoperative till end of surgery (up to 2 hours)

  4. Heart rate

    intraoperative heart rate

    Measured: every 10 minutes intraoperative till end of surgery(up to 2 hours)

  5. VAS score

    The visual analog score (VAS) 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: at 15 & 30 mins, then at 2, 6, 12, 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.

  1. First posted28 Apr 2022
  2. Study start8 May 2022
  3. Primary completion15 Sep 2022
  4. Study completion22 May 2023

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351203
Sponsor's protocol ID
MS-620-2021
Status last verified
Sep 2023
First submitted
18 Apr 2022
Last updated
26 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing caudal block and Erector spinae block in people with Acute 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 2 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 26 Sep 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?

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 analgesia request (time frame: 12 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 26 Sep 2023.

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