Quadratus Lumborum Block vs Erector Spinae Plane Block in Abdominal Hysterectomy

NCT ID: NCT05675657

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-07-15

Brief Summary

Postoperative pain following abdominal 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 abdominal 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 abdominal hysterectomy.

Detailed Description

Hysterectomy is one of the most frequently performed surgical procedures in the United States. The management of postoperative pain in gynecologic surgery is challenging.

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. 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. 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. Later on he reported posterior quadratus lumborum block (QLB) in 2013 which is known as QLB II. Børglum et. al described the transmuscular quadratus lumborum block (TQL or QLB III) in 2013 which is frequently performed in abdominal wall surgeries. 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. 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. 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. 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 abdominal hysterectomy under general anesthesia.

Conditions

Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients will be operated under general anesthesia.

Group Type: PLACEBO_COMPARATOR

No Block

Intervention Type: OTHER

The patients will receive general anesthesia.

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.

Group Type: ACTIVE_COMPARATOR

Quadratus Lumborum Block Type III

Intervention Type: PROCEDURE

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 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.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: PROCEDURE

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

Interventions

No Block

The patients will receive general anesthesia.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Control Group; QLB III; ESPB

Eligibility Criteria

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 abdominal 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Namik Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Onur Baran

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur Baran, Asst. Prof.

Role: STUDY_CHAIR

Namik Kemal University

Ayhan Şahin, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Cavidan Arar, Prof.

Role: STUDY_DIRECTOR

Namik Kemal University

Locations

Tekirdag Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Committee Opinion No 701: Choosing the Route of Hysterectomy for Benign Disease. Obstet Gynecol. 2017 Jun;129(6):e155-e159. doi: 10.1097/AOG.0000000000002112.

Reference Type: RESULT

PMID: 28538495 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26086285 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28802593 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26493289 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27687417 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35084655 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26225500 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31462804 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27501016 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30851499 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30292068 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28188621 (View on PubMed)

Baran O, Sahin A, Arar C. Comparative efficacy of erector spinae plane and quadratus lumborum blocks in managing postoperative pain for total abdominal hysterectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Oct 25;103(43):e40313. doi: 10.1097/MD.0000000000040313.

Reference Type: DERIVED

PMID: 39470511 (View on PubMed)

Other Identifiers

2022.206.11.07

Identifier Type: -

Identifier Source: org_study_id