Quadratus Lumborum Block vs Erector Spinae Plane Block in Laparoscopic Hysterectomy

NCT05465525 | Completed

• 1 other identifier: 2022.74.05.01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Disease

Keywords

Erector Spinae Plane Block; Quadratus Lumborum Block; Analgesia; Laparoscopic Hysterectomy; Ultrasound Guidance

Outcome Measures

Primary Outcomes (1)

• Total dose of opioid consumption (tramadol)

  Total dose of tramadol consumption via patient controlled device

  in the first 24 hour postoperatively

Secondary Outcomes (3)

• Visual Analog Scale

  measured at at 30 minute, 2, 6, 12, 24th hour postoperatively

• The 1st time to rescue analgesic need

  recorded within the first 24 hour postoperatively

• Postoperative nausea and vomiting

  recorded within the first 24 hour postoperatively

Study Arms (3)

Control group

PLACEBO COMPARATOR

Patients will be operated under general anesthesia.

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.

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.

Procedure: Erector Spinae Plane Block

Interventions

Quadratus Lumborum Block Type III PROCEDURE

Patients will receive ultrasound-guided quadratus lumborum block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.

Also known as: QLB III

Quadratus Lumborum Block Group

Erector Spinae Plane Block PROCEDURE

Patients will receive ultrasound-guided erector spinae plane block type III with 60 ml of bupivacaine 0.25% followed by general anesthesia.

Also known as: ESPB

Erector Spinae Plane Block Group

No Block OTHER

The patients will receive general anesthesia.

Also known as: Control Group

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity who will undergo laparoscopic hysterectomy operation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namik Kemal University

Tekirdağ, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 33082286 BACKGROUND

• 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.

  PMID: 26086285 BACKGROUND

• 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.

  PMID: 28802593 BACKGROUND

• 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.

  PMID: 26493289 BACKGROUND

• 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.

  PMID: 27687417 BACKGROUND

• 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.

  PMID: 35084655 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

• 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.

  PMID: 31462804 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30851499 BACKGROUND

• 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.

  PMID: 30292068 BACKGROUND

• 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.

  PMID: 28188621 BACKGROUND

• 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.

  BACKGROUND

• Blanco R, McDonnell J. Optimal point of injection: the quadratus lumborum type I and II blocks. Anesthesia. 2013;68:4.

  BACKGROUND

• 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).

  BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Onur Baran, Asst. Prof.

  Namik Kemal University

  STUDY CHAIR

• Ayhan Şahin, Asst. Prof.

  Namik Kemal University

  PRINCIPAL INVESTIGATOR

• Ahmet Gültekin, Asst. Prof.

  Namik Kemal University

  PRINCIPAL INVESTIGATOR

• Cavidan Arar, Prof.

  Namik Kemal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The patients will be divided randomly by a computer-generated randomization table into three equal groups.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 19, 2022
• Study Start: July 25, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)