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Anesthesia, LocalPhase 3NCT04688814

SEQ Block for Perioperative Analgesia in Acetabular Surgery

A Phase 3 study testing Single puncture combined lumbar erector spinae plane block and quadrates lumborum block and Morphine Sulfate in people with Anesthesia, Local and Nerve Pain, run by Alexandria 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

The study will evaluate ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block when compared with conventional intravenous morphine analgesia in patients undergoing posterior column acetabular fracture surgery Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia, Local, Nerve Pain, Pain, Postoperative
What is being tested?
Single puncture combined lumbar erector spinae plane block and quadrates lumborum block and Morphine Sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteEgypt
Study dates
25 Dec 2020to 15 Feb 2022
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status I-III patients
  • Unilateral posterior wall/column acetabular fractures surgery using posterior approach

Who cannot join

  • BMI > 35 kg/m2
  • Pre-existing neurological deficit
  • Spine deformity
  • Pregnancy/lactation
  • Significant renal impairment
  • Significant Hepatic impairment
  • Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection)
  • Chronic opioid users/abusers

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Alexandria Faculty of Medicine

    Alexandria, 21651

Other trials in Egypt

About this study

Official title: (SEQ Block): Single Puncture Combined Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block for Perioperative Analgesia in Acetabular Surgeries

The study will evaluate ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block when compared with conventional intravenous morphine analgesia in patients undergoing posterior column acetabular fracture surgery

Read the detailed description

Introduction: Acetabular fractures represent relatively infrequent traumatic injuries that can lead to a progressive impairment of hip articular function. Surgical treatment of these fractures may require extensive surgical dissections and frequently is associated with significant postoperative pain, delay in rehabilitation, and prolonged hospital stay. Innervation of the acetabular region is mainly provided by branches of lumbar and sacral plexuses, in addition to dorsal rami of lumbar nerve roots supplying the tissues to be dissected during posterior approach for acetabular fractures. Investigators suggest a novel approach for combined lumbar erector spinae plane block and PSSS quadratus lumborum block for perioperative analgesia in hip/acetabular surgeries using a single puncture technique (SEQ block).

Aim of the study: The primary aim of this study is to compare the total postoperative opioid (morphine) consumption after posterior column acetabular surgery when providing ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block versus conventional intravenous morphine analgesia.

The secondary aims of this study are; intraoperative and postoperative hemodynamics; Mean arterial blood pressure (MAP) and heart rate (HR), resting visual analogue scale (VAS), dynamic VAS and postoperative complications.

Methods: After obtaining approval from Alexandria university ethics committee, this study will be carried out starting from December 2020 for 1 year in Alexandria university hospital on 52 American Society of Anesthesiologists (ASA) physical status I-III patients scheduled for unilateral posterior wall/column acetabular fractures surgery using posterior approach. The exclusion criteria will include; Body mass index (BMI) > 35 kg/m2, pre-existing neurological deficit, spine deformity, pregnancy/lactation, significant renal or hepatic impairment, known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), or chronic opioid users/abusers.

Patients will be divided randomly by closed envelope method into 2 groups. Group SEQ; patients will receive ultrasound guided SEQ block preoperatively before the induction of general anaesthesia (GA).

Group MOR; patients will receive GA and analgesia will be based on opioids mainly intravenous morphine.

Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula.

Group SEQ: SEQ block is a combination of paraspinous sagittal shift (PSSS) quadratus lumborum (QL) block and erector spinae plane block (ESPB). Before the induction of GA in group SEQ, patients will lay laterally on the healthy side with the fracture side independent, a curvilinear ultrasound transducer (2-5 MHz) (Sonosite, M-turbo, Bothell, WA, USA) will be placed in a parasagittal plane 3-4 cm lateral to the lumbar spinous process of L4 (which is almost opposite to the iliac crest), producing a longitudinal scan of the lumbar paravertebral region, thus identifying the transverse processes of L3 and L4 with psoas muscle (PM) in-between and erector spinae muscle (ESM) posteriorly (superficial to transverse processes), the probe is shifted slowly to the lateral side till the transverse processes disappear and quadratus lumborum (QL) muscle is evident in its long axis attached caudally to the iliac crest with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as : ESM, QL, and PM muscles respectively. Here, anterior layer of thoracolumbar fascia (ATLF) - which is considered as a continuation of fascia transversalis - is seen separating PM and QL muscles.

After subcutaneous local infiltration with lidocaine 1% at the cephalic end of the probe, the block needle is advanced in a cephalo-caudal direction, through the erector spinae and QL muscles, until it pierces the epimysium of the QL muscle. Local anaesthetic (LA) is injected anterior to the QL, observing it's spread in a caudal direction towards the iliac crest between the QL and psoas muscles.

Then the caudal end of the probe is rotated slowly medially towards lumbar spine till the hypoechoic shadow of transverse process of L4 appears in the ultrasound image. The needle is withdrawn to subcutaneous tissue, then advanced in plane towards transverse process of L4. After contacting it, LA is deposited in the plane between transverse process and overlying ESM. Total volume of LA used will be 50 ml of 0.25 % bupivacaine, 25 ml for each injection.

While, in group MOR; no block will be given. General anaesthesia will be induced with propofol 2 mg/kg, atracurium 0.5 mg/kg, and fentanyl 1µg/kg, followed by endotracheal intubation, anaesthesia will be maintained by isoflurane 1 Minimum Alveolar Concentration (MAC) in 100% oxygen. Multimodal analgesia protocol will be provided including intravenous dexamethasone 8 mg, paracetamol 1 gm, and ketorolac 60 mg. Increments of 0.5 µg/kg of fentanyl will be given intraoperatively if there is an increase in HR/MAP above 20% of the basal value.

Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine in a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4.

Measurements:

  1. HR and MAP will be recorded preoperatively (baseline), every 30 minutes during the surgery, and every hour postoperatively for the first 4 hours, then every 4 hours for the remaining 24 hour postoperative follow up.
  2. Resting VAS every hour for the first 4 hours, then every 4 hours for the remaining 24 hour postoperative follow up.
  3. Dynamic VAS every hour for the first 4 hours, then every 4 hours for the remaining 24 hour postoperative follow up.
  4. Total analgesic requirement (intraoperative fentanyl and postoperative morphine).
  5. Postoperative complications (block or opioid related complications).
Being tested
Single puncture combined lumbar erector spinae plane block and quadrates lumborum block, Morphine Sulfate
Medical subject headings
Neuralgia, Pain, Postoperative

What participants receive

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

  • Single puncture combined lumbar erector spinae plane block and quadrates lumborum blockProcedure or surgery

    Also called SEQ group

    Patients will lay laterally with the fracture side independent, a curvilinear transducer will be placed in a parasagittal plane 3-4 cm lateral to the lumbar spinous process of L4.The probe is shifted slowly to the lateral side till the transverse processes disappear. After subcutaneous local infiltration with lidocaine 1% at the cephalic end of the probe, the block needle is advanced through the erector spinae and QL muscles, until it pierces the epimysium of the QL muscle. LA is injected anterior to the QL, between the QL and psoas muscles.

    Then the caudal end of the probe is rotated slowly medially towards lumbar spine till the transverse process of L4 appears in the ultrasound image. The needle is withdrawn to subcutaneous tissue, then advanced in plane towards transverse process of L4. After contacting it, LA is deposited between transverse process and overlying ESM.

  • Morphine SulfateDrug

    Also called MOR group

    Patients will receive GA and analgesia will be based on opioids mainly intravenous morphine

Study groups in NCT04688814
Study groupRoleWhat they receive
Morphine GroupActive comparatorPatients will receive GA and analgesia will be based on opioids mainly intravenous morphine. Intravenous morphine in a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4 postoperatively for 24 hours
Receives: Drug: Morphine Sulfate
SEQ groupExperimentalPatients will receive ultrasound guided SEQ block preoperatively before the induction of general anaesthesia. Twenty five ml of 0.25 % bupivacaine will be given in the QL plane and 25 ml of the same concentration will be given in the erector spine plane
Receives: Procedure: Single puncture combined lumbar erector spinae plane block and quadrates lumborum block

What is being measured

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

  1. Total postoperative morphine consumption

    Compare the total postoperative opioid (morphine) consumption after posterior column acetabular surgery when providing ultrasound guided SEQ block: single puncture combined lumbar erector spinae plane block and paraspinous sagittal shift (PSSS) quadratus lumborum block versus conventional intravenous morphine analgesia. Morphine 0.05 mg/kg will be given intravenously when VAS score is ≥ 4. The total postoperative morphine consumption in milligrams will be recorded.

    Measured: 24 hours postoperatively

Secondary outcomes (4)
  1. Heart rate (HR)

    HR (beats/minute) will be recorded preoperatively (baseline), every 30 minutes during the surgery, and every hour postoperatively for the first 4 hours, then every 4 hours for the remaining 24 hour postoperative follow up. Hemodynamic measurement will be done using multichannel Mindray monitor MEC-1000, mindray Ltd, Shenzhen, China

    Measured: 24 hours

  2. Mean arterial blood pressure (MABP)

    MABP (mmHg) will be recorded preoperatively (baseline), every 30 minutes during the surgery, and every hour postoperatively for the first 4 hours, then every 4 hours for the remaining 24 hour postoperative follow up. Hemodynamic measurement will be done using multichannel Mindray monitor MEC-1000, mindray Ltd, Shenzhen, China

    Measured: 24 hours

  3. Resting and dynamic visual analogue score

    Every patient will be asked postoperatively according to a visual analogue scale (VAS) score from 0 -10 about his experience with pain. Zero is equal to the best pain relief and 10 is referring to the worst pain experience. This will be also asked about during active movement of the hip joint and will be interpreted as the dynamic pain score. This will be done every hour during the 1st 4 postoperative hours and every 4 hours later for the rest 24 hour follow up period.

    Measured: 24 hours

  4. Postoperative complications

    Block or opioid related complications Nausea and vomiting: Incidence and frequency Urine retention: Incidence and frequency Any manifestation of nerve injury like the presence of paresthesia: Incidence and frequency

    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 posted30 Dec 2020
  2. Study start25 Dec 2020
  3. Primary completion25 Dec 2021
  4. Study completion15 Feb 2022

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 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04688814
Sponsor's protocol ID
0304884
Status last verified
Feb 2022
First submitted
21 Dec 2020
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared on request

Publications

  • Chelly JE, Casati A, Al-Samsam T, Coupe K, Criswell A, Tucker J. Continuous lumbar plexus block for acute postoperative pain management after open reduction and internal fixation of acetabular fractures. J Orthop Trauma. 2003 May;17(5):362-7. doi: 10.1097/00005131-200305000-00007.

    PubMed 12759641

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Single puncture combined lumbar erector spinae plane block and quadrates lumborum block and Morphine Sulfate in people with Anesthesia, Local and Nerve Pain, run by Alexandria 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 8 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 3 Mar 2022. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Total postoperative morphine consumption (time frame: 24 hours postoperatively). 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 NCT04688814, 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 3 Mar 2022.

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