Clinical trial NCT05465525: Quadratus Lumborum Block vs Erector Spinae Plane Block in Laparoscopic Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Keywords: Erector Spinae Plane Block
Quadratus Lumborum Block
Analgesia
Laparoscopic Hysterectomy
Ultrasound Guidance
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided randomly by a computer-generated randomization table into three equal groups.
Primary purpose: TREATMENT

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.

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.

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 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

Primary outcomes:
measure: Total dose of opioid consumption (tramadol)
timeFrame: in the first 24 hour postoperatively
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: measured at at 30 minute, 2, 6, 12, 24th hour postoperatively
measure: The 1st time to rescue analgesic need
timeFrame: recorded within the first 24 hour postoperatively
measure: Postoperative nausea and vomiting
timeFrame: recorded within the first 24 hour postoperatively
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdag Namik Kemal University
Study officials:
affiliation: Namik Kemal University
name: Onur Baran, Asst. Prof.
role: STUDY_CHAIR
affiliation: Namik Kemal University
name: Ayhan Şahin, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University
name: Ahmet Gültekin, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University
name: Cavidan Arar, Prof.
role: STUDY_DIRECTOR
References:
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.
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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.
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.
citation: 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.
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citation: 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.
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