Gynecologic DiseaseNCT05465525
Quadratus Lumborum Block vs Erector Spinae Plane Block in Laparoscopic Hysterectomy
A study testing Quadratus Lumborum Block Type III, Erector Spinae Plane Block and No Block in people with Gynecologic Disease, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain following laparoscopic hysterectomy is a challenging concern as some patients suffer acute pain that could let to chronic pain over time following the surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Quadratus Lumborum Block Type III, Erector Spinae Plane Block and No Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2022to 1 Apr 2023
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who accepted to participate and signed written consent
- Aged between 18 and 75
- American Society of Anesthesiologists (ASA) physical score I or II
- Elective laparoscopic hysterectomy operation
Who cannot join
- Patients who declined to participate
- BMI > 35 kg/m2
- Uncontrolled systemic disease
- <18 age and >75 age
- Unable to cooperate (mental retardation)
- Low cardiac capacity
Show all 10Show fewer
- Hypersensitivity history to the agents to be used
- Coagulopathy
- Local infections
- Opioid addiction history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Quadratus Lumborum Block Versus Erector Spinae Plane Block For Postoperative Analgesia In Patient Undergoing Laparoscopic Hysterectomy: A Randomized Double Blinded Study
Postoperative pain following laparoscopic hysterectomy is a challenging concern as some patients suffer acute pain that could let to chronic pain over time following the surgery.
Epidural analgesia which is the gold standard for postoperative pain management in abdominal surgeries including laparoscopic hysterectomy has side effects such as hypotension, hematoma, motor weakness of lower limbs, paresthesia, intrathecal placement of the epidural catheter and urinary retention that could prolong hospital stay.
Read more
Since high frequency ultrasound machines' usage has increased in postoperative analgesia management, ultrasound guided fascial plane blocks has been performed by clinicians with high success rate. To avoid possible complications of epidural catheter placement and epidural analgesia, various techniques has been applying for an analgesic effect close to the effectiveness of epidural analgesia. These techniques include transversus abdominis plane block, rectus sheath block, wound infiltration of local anesthetics, erector spinae plane block and quadratus lumborum plane block . However, each of the plane blocks has limitations individually which prevent them to be the unique analgesic technique for postoperative analgesia following abdominal surgery.
As far as the authors knowledge, there's no reported study which compares ultrasound guided erector spinae plane block versus ultrasound guided quadratus lumborum type III block (anterior quadratus lumborum block) as a preemptive analgesia technique in patients undergoing laparoscopic hysterectomy.
Read the detailed description
Total laparoscopic hysterectomy is the most preferred technique for hysterectomy in obstetric and gynecology clinics (1). The management of postoperative pain in gynecologic laparoscopic surgery is challenging (2, 3). Due to side effects of opioids such as nausea and vomiting, titration of opioid dosage for postoperative pain is difficult and effective postoperative analgesic regimes is needed (3-5).
Ultrasound guided regional anesthesia techniques such as erector spinae plane block and quadratus lumborum block for postoperative pain management has an acceleration in usage as ultrasound guidance makes the interventions safer and easier to perform, and they contribute to better pain control and pain experience (6).
Ultrasound guided quadratus lumborum block for postoperative pain management after abdominal surgery was firstly conceived by Blanco in 26th European Society of Regional Anesthesia Congress in 2007 as a variant of transversus abdominis plane (TAP) block (7). Later on he reported posterior quadratus lumborum block (QLB) in 2013 which is known as QLB II (8). Børglum et. al described the transmuscular quadratus lumborum block (TQL or QLB III) in 2013 which is frequently performed in abdominal wall surgeries (9). QLB III, transmuscular quadratus lumborum block (TQL) and anterior quadratus lumborum block; these are all synonyms and refers to injection of local anesthetic into the anterior thoracolumbar fascia (TLF) which lays between quadratus lumborum muscle and psoas major muscle (10).
Erector spinae plane block has being performed by clinicians for abdominal and thoracic surgeries since it was firstly described by Forero et al. in 2016 for analgesia in thoracic neuropathic pain (11-13). In this ultrasound guided technique local anesthetic is applied between the transverse process of the relevant thoracic or lumbar vertebrae and the erector spinae muscle which leads to the spread of the local anesthetic cephalad, caudally and through the paravertebral space (14, 15).
The investigators hypothesize that performing ultrasound-guided quadratus lumborum block will be more superior or equal to erector spinae plane block in providing postoperative analgesia for patients undergoing laparoscopic hysterectomy under general anesthesia.
- Conditions
- Gynecologic Disease
- Being tested
- Quadratus Lumborum Block Type III, Erector Spinae Plane Block, No Block
- Keywords
- Erector Spinae Plane Block, Quadratus Lumborum Block, Analgesia, Laparoscopic Hysterectomy, Ultrasound Guidance
- Medical subject headings
- Genital Diseases, Female, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum Block Type IIIProcedure or surgery
Also called QLB III
Patients will receive ultrasound-guided quadratus lumborum block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.
Erector Spinae Plane BlockProcedure or surgery
Also called ESPB
Patients will receive ultrasound-guided erector spinae plane block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.
No BlockOther
Also called Control Group
The patients will receive general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients will be operated under general anesthesia. Receives: Other: No Block |
| Quadratus Lumborum Block Group | Active comparator | Patients will receive ultrasound-guided quadratus lumborum block type III bilaterally with 30 ml of bupivacaine 0.25% on each side, totally 60 ml of bupivacaine 0.25% followed by general anesthesia. Receives: Procedure: Quadratus Lumborum Block Type III |
| Erector Spinae Plane Block Group | Active comparator | Patients will receive ultrasound-guided erector spinae plane block bilaterally with 30 ml of bupivacaine 0.25% on each side, totally 60 ml of bupivacaine 0.25% followed by general anesthesia. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of opioid consumption (tramadol)
Total dose of tramadol consumption via patient controlled device
Measured: in the first 24 hour postoperatively
Secondary outcomes (3)
Visual Analog Scale
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Measured: measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
The 1st time to rescue analgesic need
The time to ask for postoperative analgesia is the time from the end of operation to patient reporting Visual Analog Scale ≥ 4.
Measured: recorded within the first 24 hour postoperatively
Postoperative nausea and vomiting
Postoperative nausea and vomiting presence
Measured: recorded within the first 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Baran, Namik Kemal University
- Investigators
- Onur Baran, Asst. Prof., Study chair, Namik Kemal UniversityAyhan Şahin, Asst. Prof., Principal investigator, Namik Kemal UniversityAhmet Gültekin, Asst. Prof., Principal investigator, Namik Kemal UniversityCavidan Arar, Prof., Study director, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465525
- Sponsor's protocol ID
- 2022.74.05.01
- Status last verified
- Jun 2023
- First submitted
- 13 Jul 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.
PubMed 33082286Dewinter G, Teunkens A, Vermeulen K, Devroe S, Van Hemelrijck J, Meuleman C, Vergote I, Fieuws S, Van de Velde M, Rex S. Alizapride and ondansetron for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic gynaecological surgery: A double-blind, randomised, placebo-controlled noninferiority study. Eur J Anaesthesiol. 2016 Feb;33(2):96-103. doi: 10.1097/EJA.0000000000000288.
PubMed 26086285Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
PubMed 28802593Sjovall S, Kokki M, Kokki H. Laparoscopic surgery: a narrative review of pharmacotherapy in pain management. Drugs. 2015 Nov;75(16):1867-89. doi: 10.1007/s40265-015-0482-y.
PubMed 26493289Sousa AM, Rosado GM, Neto Jde S, Guimaraes GM, Ashmawi HA. Magnesium sulfate improves postoperative analgesia in laparoscopic gynecologic surgeries: a double-blind randomized controlled trial. J Clin Anesth. 2016 Nov;34:379-84. doi: 10.1016/j.jclinane.2016.05.006. Epub 2016 Jun 5.
PubMed 27687417Macias AA, Finneran JJ. Regional Anesthesia Techniques for Pain Management for Laparoscopic Surgery: a Review of the Current Literature. Curr Pain Headache Rep. 2022 Jan;26(1):33-42. doi: 10.1007/s11916-022-01000-6. Epub 2022 Jan 27.
PubMed 35084655Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500Gopal TVS. Ultrasound-guided transmuscular quadratus lumborum plane catheters: In the plane or out of it? Indian J Anaesth. 2019 Aug;63(8):609-610. doi: 10.4103/ija.IJA_585_19. No abstract available.
PubMed 31462804Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Aksu 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 30851499Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
PubMed 28188621Abd Ellatif SE, Abdelnaby SM. Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing open nephrectomy: A randomized controlled study. Egyptian Journal of Anaesthesia. 2021 2021/01/01;37(1):123-34.
Blanco R, McDonnell J. Optimal point of injection: the quadratus lumborum type I and II blocks. Anesthesia. 2013;68:4.
Børglum J, Moriggl B, Jensen K, Lønnqvist P-A, Christensen AF, Sauter A, et al. Ultrasound-guided transmuscular quadratus lumborum blockade. BJA: British Journal of Anaesthesia. 2013;111(eLetters Supplement).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Quadratus Lumborum Block Versus Erector Spinae Plane Block For Postoperative Analgesia In Patient Undergoing Laparoscopic Hysterectomy: A Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT05465525
- Acronym / sponsor ID
- 2022.74.05.01
- Conditions
- Gynecologic Disease
- Keywords
- Erector Spinae Plane Block, Quadratus Lumborum Block, Analgesia, Laparoscopic Hysterectomy, Ultrasound Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 19 Jul 2022 (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 following laparoscopic hysterectomy is a challenging concern as some patients suffer acute pain that could let to chronic pain over time following the surgery.
Epidural analgesia which is the gold standard for postoperative pain management in abdominal surgeries including laparoscopic hysterectomy has side effects such as hypotension, hematoma, motor weakness of lower limbs, paresthesia, intrathecal placement of the epidural catheter and urinary retention that could prolong hospital stay.
Since high frequency ultrasound machines' usage has increased in postoperative analgesia management, ultrasound guided fascial plane blocks has been performed by clinicians with high success rate. To avoid possible complications of epidural catheter placement and epidural analgesia, various techniques has been applying for an analgesic effect close to the effectiveness of epidural analgesia. These techniques include transversus abdominis plane block, rectus sheath block, wound infiltration of local anesthetics, erector spinae plane block and quadratus lumborum plane block . However, each of the plane blocks has limitations individually which prevent them to be the unique analgesic technique for postoperative analgesia following abdominal surgery.
As far as the authors knowledge, there's no reported study which compares ultrasound guided erector spinae plane block versus ultrasound guided quadratus lumborum type III block (anterior quadratus lumborum block) as a preemptive analgesia technique in patients undergoing laparoscopic hysterectomy.
Detailed description
Total laparoscopic hysterectomy is the most preferred technique for hysterectomy in obstetric and gynecology clinics (1). The management of postoperative pain in gynecologic laparoscopic surgery is challenging (2, 3). Due to side effects of opioids such as nausea and vomiting, titration of opioid dosage for postoperative pain is difficult and effective postoperative analgesic regimes is needed (3-5).
Ultrasound guided regional anesthesia techniques such as erector spinae plane block and quadratus lumborum block for postoperative pain management has an acceleration in usage as ultrasound guidance makes the interventions safer and easier to perform, and they contribute to better pain control and pain experience (6).
Ultrasound guided quadratus lumborum block for postoperative pain management after abdominal surgery was firstly conceived by Blanco in 26th European Society of Regional Anesthesia Congress in 2007 as a variant of transversus abdominis plane (TAP) block (7). Later on he reported posterior quadratus lumborum block (QLB) in 2013 which is known as QLB II (8). Børglum et. al described the transmuscular quadratus lumborum block (TQL or QLB III) in 2013 which is frequently performed in abdominal wall surgeries (9). QLB III, transmuscular quadratus lumborum block (TQL) and anterior quadratus lumborum block; these are all synonyms and refers to injection of local anesthetic into the anterior thoracolumbar fascia (TLF) which lays between quadratus lumborum muscle and psoas major muscle (10).
Erector spinae plane block has being performed by clinicians for abdominal and thoracic surgeries since it was firstly described by Forero et al. in 2016 for analgesia in thoracic neuropathic pain (11-13). In this ultrasound guided technique local anesthetic is applied between the transverse process of the relevant thoracic or lumbar vertebrae and the erector spinae muscle which leads to the spread of the local anesthetic cephalad, caudally and through the paravertebral space (14, 15).
The investigators hypothesize that performing ultrasound-guided quadratus lumborum block will be more superior or equal to erector spinae plane block in providing postoperative analgesia for patients undergoing laparoscopic hysterectomy under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: No BlockPatients will be operated under general anesthesia. |
| Quadratus Lumborum Block Group | Active comparator | Procedure: Quadratus Lumborum Block Type IIIPatients will receive ultrasound-guided quadratus lumborum block type III bilaterally with 30 ml of bupivacaine 0.25% on each side, totally 60 ml of bupivacaine 0.25% followed by general anesthesia. |
| Erector Spinae Plane Block Group | Active comparator | Procedure: Erector Spinae Plane BlockPatients will receive ultrasound-guided erector spinae plane block bilaterally with 30 ml of bupivacaine 0.25% on each side, totally 60 ml of bupivacaine 0.25% followed by general anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who accepted to participate and signed written consent
- Aged between 18 and 75
- American Society of Anesthesiologists (ASA) physical score I or II
- Elective laparoscopic hysterectomy operation
Key exclusion criteria (10 listed)
- Patients who declined to participate
- BMI > 35 kg/m2
- Uncontrolled systemic disease
- <18 age and >75 age
- Unable to cooperate (mental retardation)
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 |
|---|---|---|
| Quadratus Lumborum Block Type IIIAlso: QLB IIIPatients will receive ultrasound-guided quadratus lumborum block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia. | Procedure or surgery | Quadratus Lumborum Block Group |
| Erector Spinae Plane BlockAlso: ESPBPatients will receive ultrasound-guided erector spinae plane block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia. | Procedure or surgery | Erector Spinae Plane Block Group |
| No BlockAlso: Control GroupThe patients will receive general anesthesia. | Other | Control group |
Primary outcome
Total dose of opioid consumption (tramadol)
Time frame: in the first 24 hour postoperatively
Total dose of tramadol consumption via patient controlled device
3 secondary outcomes
Visual Analog Scale
Time frame: measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
The 1st time to rescue analgesic need
Time frame: recorded within the first 24 hour postoperatively
Postoperative nausea and vomiting
Time frame: recorded within the first 24 hour postoperatively
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 13 Jun 2023.
- Background: PubMed 33082286Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.
- Background: PubMed 26086285Dewinter G, Teunkens A, Vermeulen K, Devroe S, Van Hemelrijck J, Meuleman C, Vergote I, Fieuws S, Van de Velde M, Rex S. Alizapride and ondansetron for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic gynaecological surgery: A double-blind, randomised, placebo-controlled noninferiority study. Eur J Anaesthesiol. 2016 Feb;33(2):96-103. doi: 10.1097/EJA.0000000000000288.
- Background: PubMed 28802593Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
- Background: PubMed 26493289Sjovall S, Kokki M, Kokki H. Laparoscopic surgery: a narrative review of pharmacotherapy in pain management. Drugs. 2015 Nov;75(16):1867-89. doi: 10.1007/s40265-015-0482-y.
- Background: PubMed 27687417Sousa AM, Rosado GM, Neto Jde S, Guimaraes GM, Ashmawi HA. Magnesium sulfate improves postoperative analgesia in laparoscopic gynecologic surgeries: a double-blind randomized controlled trial. J Clin Anesth. 2016 Nov;34:379-84. doi: 10.1016/j.jclinane.2016.05.006. Epub 2016 Jun 5.
- Background: PubMed 35084655Macias AA, Finneran JJ. Regional Anesthesia Techniques for Pain Management for Laparoscopic Surgery: a Review of the Current Literature. Curr Pain Headache Rep. 2022 Jan;26(1):33-42. doi: 10.1007/s11916-022-01000-6. Epub 2022 Jan 27.
- Background: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Background: PubMed 31462804Gopal TVS. Ultrasound-guided transmuscular quadratus lumborum plane catheters: In the plane or out of it? Indian J Anaesth. 2019 Aug;63(8):609-610. doi: 10.4103/ija.IJA_585_19. No abstract available.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- 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 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Background: PubMed 28188621Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
- Individual participant dataSharing planned: No
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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.
Onur Baran, Asst. Prof. study chair
Namik Kemal University
Ayhan Şahin, Asst. Prof. principal investigator
Namik Kemal University
Ahmet Gültekin, Asst. Prof. principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block Type III, Erector Spinae Plane Block and No Block in people with Gynecologic Disease, run by Namik Kemal 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 4 inclusion and 10 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 13 Jun 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. Some participants in this study may receive a placebo. 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?
Total dose of opioid consumption (tramadol) (time frame: in the first 24 hour 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 NCT05465525, which also lists 15 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 13 Jun 2023.