- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05465525
Quadratus Lumborum Block vs Erector Spinae Plane Block in Laparoscopic Hysterectomy
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Onur Baran, Asst. Prof.
- Phone Number: +905393422582
- Email: dronurbaran@hotmail.com
Study Locations
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-
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Tekirdağ, Turkey
- Tekirdag Namik Kemal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Hypersensitivity history to the agents to be used
- Coagulopathy
- Local infections
- Opioid addiction history
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
Patients will be operated under general anesthesia.
|
The patients will receive general anesthesia.
Other Names:
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Active Comparator: Quadratus Lumborum Block Group
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.
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Patients will receive ultrasound-guided quadratus lumborum block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
|
Active Comparator: Erector Spinae Plane Block Group
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.
|
Patients will receive ultrasound-guided erector spinae plane block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total dose of opioid consumption (tramadol)
Time Frame: in the first 24 hour postoperatively
|
Total dose of tramadol consumption via patient controlled device
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in the first 24 hour postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
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On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
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measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
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The 1st time to rescue analgesic need
Time Frame: recorded within the first 24 hour postoperatively
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The time to ask for postoperative analgesia is the time from the end of operation to patient reporting Visual Analog Scale ≥ 4.
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recorded within the first 24 hour postoperatively
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Postoperative nausea and vomiting
Time Frame: recorded within the first 24 hour postoperatively
|
Postoperative nausea and vomiting presence
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recorded within the first 24 hour postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Onur Baran, Asst. Prof., Tekirdag Namik Kemal University
- Principal Investigator: Ayhan Şahin, Asst. Prof., Tekirdag Namik Kemal University
- Study Director: Cavidan Arar, Prof., Tekirdag Namik Kemal University
- Principal Investigator: Ahmet Gültekin, Asst. Prof., Tekirdag Namik Kemal University
Publications and helpful links
General Publications
- Blanco 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.
- Forero 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.
- Sjovall 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.
- Chin 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.
- Tsui 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.
- Sousa 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.
- 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.
- Ishio 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.
- 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.
- Dewinter 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.
- Macias 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.
- Gopal 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.
- Abd 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022.74.05.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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