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).
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
- Conditions the study is for
- Postoperative Analgesia, Intraoperative Analgesia
- What is being tested?
- Erector Spinae Plane Block and Quadratus Lumborum Block (QLB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- Conditions
- Postoperative Analgesia, Intraoperative Analgesia
- 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 group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | Group that Erector spinae plane block was applied. Receives: Procedure: Erector Spinae Plane Block |
| Grup Q | Active comparator | Group that Quadratus lumborum type II block was applied Receives: Procedure: Quadratus Lumborum Block (QLB) |
| Group K | No intervention | no block was applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of postoperative analgesia
visuel analog score < 3
Measured: postoperative 24 hours
Secondary outcomes (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.
- First posted28 Oct 2024
- Study start30 Sep 2022
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muharrem Baturu, University of Gaziantep
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 38239121Kolacz 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 32175985Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06660953
- Acronym / sponsor ID
- ESB vs QLB in transplatation
- Conditions
- Postoperative Analgesia, Intraoperative Analgesia
- Keywords
- errector spina plane block, quadratus lumborum block, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- randomised controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Procedure: Erector Spinae Plane BlockGroup that Erector spinae plane block was applied. |
| Grup Q | Active comparator | Procedure: Quadratus Lumborum Block (QLB)Group that Quadratus lumborum type II block was applied |
| Group K | No intervention | –no block was applied |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockFor 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. | Procedure or surgery | Group E |
| Quadratus Lumborum Block (QLB)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 | Procedure or surgery | Grup Q |
Primary outcome
Effectiveness of postoperative analgesia
Time frame: postoperative 24 hours
visuel analog score < 3
1 secondary outcome
consumption of add analgesic dos
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 38239121Atici 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.
- Results publication: PubMed 32175985Kolacz 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.
- Results publication: PubMed 37704438Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.