Pain, PostoperativeNCT04459624
Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy
A study testing Erector Spina Plane Block and Quadratus Lumborum Block 2 in people with Pain, Postoperative and Postoperative Complications, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. It is associated with postoperative morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Postoperative Complications
- What is being tested?
- Erector Spina Plane Block and Quadratus Lumborum Block 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 31 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partial or radical nephrectomy
- American Society of Anesthesiologist physical status I-III
Who cannot join
- Infection in the incision area
- Coagulation disorder
- Known allergy history against to the study drugs
- Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi Univercıty
Odunpazari, Eskişehir, 26040
About this study
Official title: Comparison of the Effects of Quadratus Lumborum Block (QLB) and Erector Spina Plane Block (ESP) on Postoperative Pain in Open Nephrectomy
Postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. It is associated with postoperative morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional analgesia consumption, patient and surgeon satisfaction.
Read the detailed description
At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, initial analgesic requirement, nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon satisfaction, and postoperative complications will be recorded.
- Conditions
- Pain, Postoperative, Postoperative Complications
- Being tested
- Erector Spina Plane Block, Quadratus Lumborum Block 2
- Keywords
- Erector Spina Plan Block, Quadratus Lumborum Block, Nephrectomy, Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spina Plane BlockProcedure or surgery
Also called Fascial plane block at nephrectomy
Group E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
Quadratus Lumborum Block 2Procedure or surgery
Also called Fascial plane block at nephrectomy
Group Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| ESP block | Active comparator | Intervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine Receives: Procedure: Erector Spina Plane Block |
| QLB 2 block | Active comparator | Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine Receives: Procedure: Quadratus Lumborum Block 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
Measured: 24 hours
Secondary outcomes (1)
Total opiate consumption
Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start20 Jul 2020
- Primary completion20 Jul 2021
- Study completion31 Jan 2022
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 Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group E: ESP block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 \* 1 and tramadol 1mg/kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period. Group Q: QLB2 block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 \* 1 and tramadol 1mg / kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Onay, Eskisehir Osmangazi University
- Investigators
- Meryem Onay, Dr, Principal investigator, Eskisehir Osmangazi University Faculty Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459624
- Sponsor's protocol ID
- ESOGU 2
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2020
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
PubMed 30851499Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PubMed 28759502Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 10.4103/aer.AER_108_18.
PubMed 30283187
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Quadratus Lumborum Block (QLB) and Erector Spina Plane Block (ESP) on Postoperative Pain in Open Nephrectomy
- ClinicalTrials.gov ID
- NCT04459624
- Acronym / sponsor ID
- ESOGU 2
- Conditions
- Pain, Postoperative, Postoperative Complications
- Keywords
- Erector Spina Plan Block, Quadratus Lumborum Block, Nephrectomy, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 7 Jul 2020 (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.
Postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. It is associated with postoperative morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional analgesia consumption, patient and surgeon satisfaction.
Detailed description
At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, initial analgesic requirement, nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon satisfaction, and postoperative complications will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group E: ESP block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 * 1 and tramadol 1mg/kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period. Group Q: QLB2 block will be applied at the end of the operation. Patients will receive paracetamol 1gr 4 * 1 and tramadol 1mg / kg 30 minutes before the end of the operation. All patients will undergo IV morphine patient-controlled analgesia (PCA). Pain, opioid consumption, hemodynamic parameters and complications will be monitored in the first 24 hours in the postoperative period.
| Arm | Type | Receives |
|---|---|---|
| ESP block | Active comparator | Procedure: Erector Spina Plane BlockIntervention: Erector Spina Plane Block will administer with 20 ml of % 0.25 bupivacaine |
| QLB 2 block | Active comparator | Procedure: Quadratus Lumborum Block 2Intervention: Quadratus Lumborum Block 2 will administer with 20 ml of % 0.25 bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Partial or radical nephrectomy
- American Society of Anesthesiologist physical status I-III
Key exclusion criteria (4 listed)
- Infection in the incision area
- Coagulation disorder
- Known allergy history against to the study drugs
- Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS
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 Spina Plane BlockAlso: Fascial plane block at nephrectomyGroup E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist. | Procedure or surgery | ESP block |
| Quadratus Lumborum Block 2Also: Fascial plane block at nephrectomyGroup Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist. | Procedure or surgery | QLB 2 block |
Primary outcome
Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery
Time frame: 24 hours
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
1 secondary outcome
Total opiate consumption
Time frame: 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 4 Feb 2022.
- Background: PubMed 30851499Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 28759502Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
- Background: PubMed 30283187Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 10.4103/aer.AER_108_18.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Meryem Onay, Dr principal investigator
Eskisehir Osmangazi University Faculty Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spina Plane Block and Quadratus Lumborum Block 2 in people with Pain, Postoperative and Postoperative Complications, run by Eskisehir Osmangazi University 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 2 inclusion and 4 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 4 Feb 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 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?
Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery (time frame: 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 NCT04459624, 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 4 Feb 2022.