Postprocedural AnalgesiaNCT05845788
Comparison of the Intraoperative and Postoperative Effects of Ultrasound-guided Erector Spina Plane Block and Posterior Quadratus Lumborum Block in Patients Undergoing Lumbar Stabilization Surgery
An observational study of Postprocedural Analgesia and Opioid Consumption, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the effects of ultrasound guided erector spina plan block and posterior quadratus lumborum block on intraoperative and postoperative opioid consumption in patients who will undergo short segment lumbar stabilization surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postprocedural Analgesia, Opioid Consumption, Erector Spina Plan Block
- What is being tested?
- Peripheral nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 2 Aug 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo lumbar stabilization operation under general anesthesia in Ankara Bilkent City Hospital Operating Room, between the ages of 18-65, both genders, and in the ASA I-III risk group will be included in the study.
Who may be able to join
- Patients who will undergo lumbar stabilization operation
- Between the ages of 18-65
- Both genders
- ASA I-III risk group
Who cannot join
- Patients who did not accept the study
- Patients younger than 18 years old
- Patients older than 65 years
- Patients with an ASA score greater than III
- Patients with an active infection in the area to be blocked
- Patients with a long bleeding time
Show all 13Show fewer
- Those who are pregnant
- Patients with kidney failure
- Patients with liver failure
- Patients with BMI<18 and BMI>30
- Those who are allergic to local anesthetics
- Patients who have had previous lumbar surgery
- Uncooperative or mentally retarded patients
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aimed to compare the effects of ultrasound guided erector spina plan block and posterior quadratus lumborum block on intraoperative and postoperative opioid consumption in patients who will undergo short segment lumbar stabilization surgery.
Read the detailed description
All participants will be monitored with ECG, SpO2, non-invasive blood pressure. In induction, 1mg/kg 2% lidocaine, 2-3mg/kg propofol, 1mcg/kg fentanyl, 2mg midazolam, 0.6 mg/kg rocuronium will be used. Anesthesia depth will be monitored with BIS (bispectral index), and anesthesia will be maintained with 50% oxygen-air mixture and sevoflurane. After patient intubation, invasive artery cannulation will be performed on the non-dominant hand, and the patients will be placed in a prone position. 20 cc bupivacaine of 0.25% will be administered to both regions bilaterally, by following the rules of asepsis, with a 10 cm pajunk needle accompanied by USG, the needle site will be confirmed with 3 mm saline.
BIS will be kept in the range of 40-50 throughout the case, and invasive arterial monitoring will be performed. 1 g paracetamol, 1 mg/kg tramadol and 4 mg ondansetron will be administered to the patients 30 minutes before the end of the surgery.
After appropriate extubation and wakefulness, patients will be transferred to the postoperative anesthesia care unit (PACU), where they will be followed for 24 hours.
An intravenous (IV) patient-controlled analgesia device (PCA) containing 100ml of tramadol at a concentration of 4mg/cc will be inserted. No infusion will be given, and the bolus dose will be set to 20mg, with a lock time of 20 minutes. In the postoperative period, 50 mg of dexketoprofen will be administered every 8 hours.
VAS values, vital signs, and possible opioid side effects of the patients at 0, 1, 2, 6, 12 and 24 hours will be recorded. After completing 24 hours, the patient will be separated from the IV PCA device and transferred to the service.
- Conditions
- Postprocedural Analgesia, Opioid Consumption, Erector Spina Plan Block, Quadratus Lumborum Block
- Being tested
- Peripheral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve blockProcedure or surgery
Ultrasound guided peripheral nerve block
| Study group | Role | What they receive |
|---|---|---|
| Erector Spina Plan Block Group (Group E) | Patients who underwent erector spina plane block before initiation of surgery after induction of anesthesia Receives: Procedure: Peripheral nerve block | |
| Posterior Quadratus Lumborum Block Group ( Group Q) | Patients who underwent posterior quadratus lumborum block block before initiation of surgery after induction of anesthesia Receives: Procedure: Peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
İntraoperative remifentanil consumption
The investigators aimed to compare intraoperative remifentanil consumption of two groups
Measured: At the end of the intraoperative period
Postoperative tramadol consumption
The investigators aimed to compare postoperative tramadol consumption of two groups
Measured: The investigators will record at postoperative 0. hour
Postoperative tramadol consumption
The investigators aimed to compare postoperative tramadol consumption of two groups
Measured: The investigators will record at postoperative 1. hour
Postoperative tramadol consumption
The investigators aimed to compare postoperative tramadol consumption of two groups
Measured: The investigators will record at postoperative 2. hour
Postoperative tramadol consumption
The investigators aimed to compare postoperative tramadol consumption of two groups
Measured: The investigators will record at postoperative 6. hour
Postoperative tramadol consumption
The investigators aimed to compare postoperative tramadol consumption of two groups
Measured: The investigators will record at postoperative 12. hour
Postoperative tramadol consumption
The investigators aimed to compare postoperative tramadol consumption of two groups
Measured: The investigators will record at postoperative 24. hour
Secondary outcomes (8)
Postoperative nausea and vomiting
Whether there is postoperative nausea and vomiting will be questioned by the investigators. Yes or no will be marked in the table.
Measured: The investigators will record within 24 hours postoperatively.
Postoperative pruritus
Whether there is postoperative pruritus will be questioned by the investigators. Yes or no will be marked in the table.
Measured: The investigators will record within 24 hours postoperatively.
Postoperative visual analog scale
The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.
Measured: The investigators will record at postoperative 0. hour
Postoperative visual analog scale
The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.
Measured: We will record at postoperative 1. hour
Postoperative visual analog scale
The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.
Measured: The investigators will record at postoperative 2. hour
Postoperative visual analog scale
The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.
Measured: The investigators will record at postoperative 6. hour
Postoperative visual analog scale
The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.
Measured: The investigators will record at postoperative 12. hour
Postoperative visual analog scale
The investigators aimed to compare patient's visual analog scales of two groups. The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain, 10 indicates severe pain.
Measured: The investigators will record at postoperative 24. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Apr 2023
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postprocedural AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal Gökbulut Özaslan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845788
- Sponsor's protocol ID
- E1-23-.3166
- Status last verified
- Oct 2023
- First submitted
- 9 Mar 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
PubMed 32669870Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
PubMed 30725897Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
PubMed 30688787Kang R, Lee S, Kim GS, Jeong JS, Gwak MS, Kim JM, Choi GS, Cho YJ, Ko JS. Comparison of Analgesic Efficacy of Erector Spinae Plane Block and Posterior Quadratus Lumborum Block in Laparoscopic Liver Resection: A Randomized Controlled Trial. J Pain Res. 2021 Dec 11;14:3791-3800. doi: 10.2147/JPR.S343366. eCollection 2021.
PubMed 34924770
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Intraoperative and Postoperative Effects of Ultrasound-guided Erector Spina Plane Block and Posterior Quadratus Lumborum Block in Patients Undergoing Lumbar Stabilization Surgery
- ClinicalTrials.gov ID
- NCT05845788
- Acronym / sponsor ID
- E1-23-.3166
- Conditions
- Postprocedural Analgesia, Opioid Consumption, Erector Spina Plan Block, Quadratus Lumborum Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 6 May 2023 (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.
The investigators aimed to compare the effects of ultrasound guided erector spina plan block and posterior quadratus lumborum block on intraoperative and postoperative opioid consumption in patients who will undergo short segment lumbar stabilization surgery.
Detailed description
All participants will be monitored with ECG, SpO2, non-invasive blood pressure. In induction, 1mg/kg 2% lidocaine, 2-3mg/kg propofol, 1mcg/kg fentanyl, 2mg midazolam, 0.6 mg/kg rocuronium will be used. Anesthesia depth will be monitored with BIS (bispectral index), and anesthesia will be maintained with 50% oxygen-air mixture and sevoflurane. After patient intubation, invasive artery cannulation will be performed on the non-dominant hand, and the patients will be placed in a prone position. 20 cc bupivacaine of 0.25% will be administered to both regions bilaterally, by following the rules of asepsis, with a 10 cm pajunk needle accompanied by USG, the needle site will be confirmed with 3 mm saline.
BIS will be kept in the range of 40-50 throughout the case, and invasive arterial monitoring will be performed. 1 g paracetamol, 1 mg/kg tramadol and 4 mg ondansetron will be administered to the patients 30 minutes before the end of the surgery.
After appropriate extubation and wakefulness, patients will be transferred to the postoperative anesthesia care unit (PACU), where they will be followed for 24 hours.
An intravenous (IV) patient-controlled analgesia device (PCA) containing 100ml of tramadol at a concentration of 4mg/cc will be inserted. No infusion will be given, and the bolus dose will be set to 20mg, with a lock time of 20 minutes. In the postoperative period, 50 mg of dexketoprofen will be administered every 8 hours.
VAS values, vital signs, and possible opioid side effects of the patients at 0, 1, 2, 6, 12 and 24 hours will be recorded. After completing 24 hours, the patient will be separated from the IV PCA device and transferred to the service.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spina Plan Block Group (Group E) | – | Procedure: Peripheral nerve blockPatients who underwent erector spina plane block before initiation of surgery after induction of anesthesia |
| Posterior Quadratus Lumborum Block Group ( Group Q) | – | Procedure: Peripheral nerve blockPatients who underwent posterior quadratus lumborum block block before initiation of surgery after induction of anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo lumbar stabilization operation under general anesthesia in Ankara Bilkent City Hospital Operating Room, between the ages of 18-65, both genders, and in the ASA I-III risk group will be included in the study.
Key inclusion criteria (4 listed)
- Patients who will undergo lumbar stabilization operation
- Between the ages of 18-65
- Both genders
- ASA I-III risk group
Key exclusion criteria (13 listed)
- Patients who did not accept the study
- Patients younger than 18 years old
- Patients older than 65 years
- Patients with an ASA score greater than III
- Patients with an active infection in the area to be blocked
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 |
|---|---|---|
| Peripheral nerve blockUltrasound guided peripheral nerve block | Procedure or surgery | Erector Spina Plan Block Group (Group E), Posterior Quadratus Lumborum Block Group ( Group Q) |
Primary outcome
İntraoperative remifentanil consumption
Time frame: At the end of the intraoperative period
The investigators aimed to compare intraoperative remifentanil consumption of two groups
Postoperative tramadol consumption
Time frame: The investigators will record at postoperative 0. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
Postoperative tramadol consumption
Time frame: The investigators will record at postoperative 1. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
Postoperative tramadol consumption
Time frame: The investigators will record at postoperative 2. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
Postoperative tramadol consumption
Time frame: The investigators will record at postoperative 6. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
Postoperative tramadol consumption
Time frame: The investigators will record at postoperative 12. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
Postoperative tramadol consumption
Time frame: The investigators will record at postoperative 24. hour
The investigators aimed to compare postoperative tramadol consumption of two groups
8 secondary outcomes
Postoperative nausea and vomiting
Time frame: The investigators will record within 24 hours postoperatively.
Postoperative pruritus
Time frame: The investigators will record within 24 hours postoperatively.
Postoperative visual analog scale
Time frame: The investigators will record at postoperative 0. hour
Postoperative visual analog scale
Time frame: We will record at postoperative 1. hour
Postoperative visual analog scale
Time frame: The investigators will record at postoperative 2. hour
Postoperative visual analog scale
Time frame: The investigators will record at postoperative 6. hour
Postoperative visual analog scale
Time frame: The investigators will record at postoperative 12. hour
Postoperative visual analog scale
Time frame: The investigators will record at postoperative 24. hour
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 2 Nov 2023.
- Background: PubMed 32669870Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
- Background: PubMed 30725897Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
- Background: PubMed 30688787Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Background: PubMed 34924770Kang R, Lee S, Kim GS, Jeong JS, Gwak MS, Kim JM, Choi GS, Cho YJ, Ko JS. Comparison of Analgesic Efficacy of Erector Spinae Plane Block and Posterior Quadratus Lumborum Block in Laparoscopic Liver Resection: A Randomized Controlled Trial. J Pain Res. 2021 Dec 11;14:3791-3800. doi: 10.2147/JPR.S343366. eCollection 2021.
- Individual participant dataSharing planned: No
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?
An observational study of Postprocedural Analgesia and Opioid Consumption, run by Ankara City Hospital Bilkent 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 4 inclusion and 13 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 2 Nov 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 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.
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?
İntraoperative remifentanil consumption (time frame: At the end of the intraoperative period). The study lists 7 primary outcomes in all. 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 NCT05845788, which also lists 4 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 2 Nov 2023.