Quadratus Lumborum Block vs Erector Spinae Plane Block in Laparoscopic Hysterectomy

Gynecologic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465525
• Other study ID #: 2022.74.05.01
• Status: Completed
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2023
• Source: Namik Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Procedure:
• Quadratus Lumborum Block Type 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 Block
Patients will receive ultrasound-guided erector spinae plane block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.

Other:
• No Block
The patients will receive general anesthesia.

Locations

Country	Name	City	State
Turkey	Tekirdag Namik Kemal University	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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.

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. — View Citation

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. — View Citation

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).

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of opioid consumption (tramadol)	Total dose of tramadol consumption via patient controlled device	in the first 24 hour postoperatively
Secondary	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 at at 30 minute, 2, 6, 12, 24th hour postoperatively
Secondary	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.	recorded within the first 24 hour postoperatively
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting presence	recorded within the first 24 hour postoperatively