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Postoperative AnalgesiaPhase 4NCT06660953

Comparison of Analgesic Efficacy ESP Block and QLB II in Kidney Transplantation

A Phase 4 study testing Erector Spinae Plane Block and Quadratus Lumborum Block (QLB) in people with Postoperative Analgesia and Intraoperative Analgesia, run by University of Gaziantep at 1 site in Turkey (Türkiye).

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

Renal transplantation is an increasingly common surgery in recent years. Opioid and/or NSAID use is common in postoperative pain management. However, these drugs have many side effects. Peripheral blocks provide more effective analgesia both intra and postoperatively, and also reduce the use of systemic drugs. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Erector Spinae Plane Block and Quadratus Lumborum Block (QLB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Sep 2022to 30 Mar 2023
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -

Who cannot join

  • Patients with a history of allergy to general and local anesthetics to be used, inability to understand or participate in pain scoring, inability to use the PCA pump, or conditions that prevent the performance of trunkal blocks (anatomical or postoperative deformations in the region)
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Gaziantep

    Gaziantep, 27031

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Intraopertaive and Postoperative Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum II and Errector Spinae Plane Block in Patients Undergoing Kidney Transplantation

Renal transplantation is an increasingly common surgery in recent years. Opioid and/or NSAID use is common in postoperative pain management. However, these drugs have many side effects. Peripheral blocks provide more effective analgesia both intra and postoperatively, and also reduce the use of systemic drugs. The aim of this study was to compare the effects of two different nerve blocks (ESP vs QLB II) on intraoperative remifentanil dose and postoperative analgesia.

Read the detailed description

All patients participating in this study underwent a standard anesthesia induction and maintenance. When the patients arrived in the operating room, noninvasive blood pressure, heart rate, electrocardiogram, and oxygen saturation monitoring were performed. Intravenous administration of 2-3 mg/kg propofol, 1-2 mcg/kg Fentanyl, and 0.1 mg/kg atracurium was performed for general anesthesia induction, and then the patients were intubated. After tracheal intubation, anesthesia was maintained with 50% oxygen/air and sevoflurane. An additional 0.1 mg/kg atracurium was added during the surgery as needed. Analgesia was provided with 0.1-0.3 mcg/kg/h intravenous infusion of remifentanil, which was increased or decreased according to the patient's hemodynamics. Intravenous neostigmine was administered for neuromuscular recovery after the surgery. The patient awoke from general anesthesia. Total anesthesia duration, hemodynamic data, and remifentanil dose were recorded.

Patients who would receive a block after general anesthesia induction were randomly determined. These patients were placed in the lateral decubitus position and ESP block or QLB II was applied under ultrasound guidance and echogenic needle (Techniplex 18 gauge; 100 mm needle, Vygon value life) under aseptic conditions. All interventions were performed by an experienced anesthesiology specialist. All procedures were performed under ultrasound guidance using a linear probe (Logiq e GE 12L-RS linear probe, GE LOGIQ e Ultrason device). Patients were randomly divided into 3 groups. Patients who underwent ESB were named Group E, those who underwent QLB were named Group Q, and patients who did not receive a block were named the control group.

The QL block II was done under aseptic technique, in lateral position with the side intended to block side up. A high frequency ultrasound linear probe covered in sterile sheath was placed anterior and superior to the iliac crest. The three anterior abdominal muscles were visualized. The external oblique muscle was followed posterolaterally until its posterior border was identified. Subsequently, the probe was tilted towards the attachment site of both the internal and external oblique muscles over the quadratus (QL) muscle until the midline of the thoracolumbar fascia was seen as a bright hyperechogenic line located between the posterior border of the quadratus lumborum muscle and the middle thoraco-lumbar fascia (anterior to latissiumus dorsi and erector spinae muscles). A 22-gauge Facet-tip SonoPlex needle of appropriate length estimated from the depth and length of required needle trajectory during scout scanning was inserted via in-plane technique. The needle was directed from anterolateral to posteromedial after making a negative aspiration test with aliquots of 0.5 ml saline to confirm hydrodissection in the lumbar interfascial triangle (LIFT) between the QL muscle and middle thoracolumbar fascia. An injection of LA was given according to the group allocated. Aliquots of LA with intermittent aspiration during injection was performed in the desired confirmed space After the needle tip was correctly positioned, 10 ml of bupivacaine and 10 ml of 0.9% saline solution were injected.

For ESP, high frequency linear ultrasound probe was planned transversely to the midline and spinous features were visualized. Cervical C7 and T7 vertebrae at the lower end of the scapula, which were accepted as landmarks, were determined and marked with a sterile surgical drawing pen. According to these landmarks, the USG probe was moved 2-3 cm laterally towards the points where kidney transplantation was planned at the T10 vertebral level, and the transverse parts, trapezius, latissimus dorsi, serratus and erector spina muscles were visualized. Using the block needle that can be visualized on USG with in-plane surgery, the skin, subcutaneous tissue and trapezius, latissimus dorsi, serratus and erector spina muscles were passed in a cranio caudal direction and the needle location was confirmed by hydrodissection with 2-5 ml of serum. The distribution of the block procedure and the spread of local anesthetic were linearly visualized with 10 ml bupivacaine and 10 ml 0.9% saline.

The control group received 0.1 mg/kg morphine subcutaneously 30 minutes before the end of the operation. All patients were connected to a patient-controlled analgesia device (1 mg Fentanyl/100 ml saline, 2 ml bolus dose, 15 min lock, infusion rate 2 ml/h).

Postoperatively, total 24-hour fentanyl consumption and pain scores of all patients were recorded according to the visual analog scale at 1, 2, 3, 4, 6, 12 and 24 hours.

Being tested
Erector Spinae Plane Block, Quadratus Lumborum Block (QLB)
Keywords
errector spina plane block, quadratus lumborum block, postoperative pain
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

    For ESP, high frequency linear ultrasound probe was planned transversely to the midline and spinous features were visualized. Cervical C7 and T7 vertebrae at the lower end of the scapula, which were accepted as landmarks, were determined and marked with a sterile surgical drawing pen. According to these landmarks, the USG probe was moved 2-3 cm laterally towards the points where kidney transplantation was planned at the T10 vertebral level, and the transverse parts, trapezius, latissimus dorsi, serratus and erector spina muscles were visualized. Using the block needle that can be visualized on USG with in-plane surgery, the skin, subcutaneous tissue and trapezius, latissimus dorsi, serratus and erector spina muscles were passed in a cranio caudal direction and the needle location was confirmed by hydrodissection with 2-5 ml of serum. The distribution of the block procedure and the spread of local anesthetic were linearly visualized with 10 ml bupivacaine and 10 ml 0.9% saline.

  • Quadratus Lumborum Block (QLB)Procedure or surgery

    The QL block II was done under aseptic technique, in lateral position with the side intended to block side up. A high frequency ultrasound linear probe covered in sterile sheath was placed anterior and superior to the iliac crest. The three anterior abdominal muscles were visualized. The external oblique muscle was followed posterolaterally until its posterior border was identified. Subsequently, the probe was tilted towards the attachment site of both the internal and external oblique muscles over the quadratus (QL) muscle until the midline of the thoracolumbar fascia was seen as a bright hyperechogenic line located between the posterior border of the quadratus lumborum muscle and the middle thoraco-lumbar fascia (anterior to latissiumus dorsi and erector spinae muscles). A 22-gauge Facet-tip SonoPlex needle of appropriate length estimated from the depth and length of required needle trajectory during scout scanning was inserted via in-plane technique. The needle was directed from a

Study groups in NCT06660953
Study groupRoleWhat they receive
Group EActive comparatorGroup that Erector spinae plane block was applied.
Receives: Procedure: Erector Spinae Plane Block
Grup QActive comparatorGroup that Quadratus lumborum type II block was applied
Receives: Procedure: Quadratus Lumborum Block (QLB)
Group KNo interventionno block was applied

What is being measured

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

  1. Effectiveness of postoperative analgesia

    visuel analog score < 3

    Measured: postoperative 24 hours

Secondary outcomes (1)
  1. consumption of add analgesic dos

    Reduction in consumption of additional analgesic administered (fentanyl PCA)

    Measured: postoperative 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 posted28 Oct 2024
  2. Study start30 Sep 2022
  3. Primary completion28 Feb 2023
  4. Study completion30 Mar 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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Model description
randomised controlled clinical study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660953
Sponsor's protocol ID
ESB vs QLB in transplatation
Other IDs
2022/172
Status last verified
Oct 2024
First submitted
24 Oct 2024
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Atici E, Arslan ZI, Yilmaz H. Effect of erector spinae plane block on postoperative intravenous morphine consumption in open subcostal nephrectomy: A prospective randomized clinical trial. Agri. 2024 Jan;36(1):13-21. doi: 10.14744/agri.2022.71602.

    PubMed 38239121
  • Kolacz M, Mieszkowski M, Janiak M, Zagorski K, Byszewska B, Weryk-Dysko M, Onichimowski D, Trzebicki J. Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia in renal transplantation: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):773-789. doi: 10.1097/EJA.0000000000001193.

    PubMed 32175985
  • Kim Y, Kim JT, Yang SM, Kim WH, Han A, Ha J, Min S, Park SK. Anterior quadratus lumborum block for analgesia after living-donor renal transplantation: a double-blinded randomized controlled trial. Reg Anesth Pain Med. 2024 Aug 5;49(8):550-557. doi: 10.1136/rapm-2023-104788.

    PubMed 37704438

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erector Spinae Plane Block and Quadratus Lumborum Block (QLB) in people with Postoperative Analgesia and Intraoperative Analgesia, run by University of Gaziantep at 1 site in Turkey (Türkiye).

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 2 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 Oct 2024. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Effectiveness of postoperative analgesia (time frame: postoperative 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 NCT06660953, which also lists 3 linked publications.

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 Oct 2024.

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