Clinical trial NCT03421821: The Difference Between the Extrafascial Injection and the Subfascial Injection of Quadratus Lumborum Block
Official title: Extrafascial Injection Versus Subfascial Injection of Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: quadratus lumborum block
anterior thoracolumbar fascia
subfascial injection
extrafascial injection
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators random divided subjects into two groups, the "subfascial injection group"and the "extrafascial injection group". Two groups were injected 0.33% ropivacaine 30 ml to the target location.
Primary purpose: TREATMENT

Brief summary: Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. But the lower thoracic to the hip dermatome can't be blocked at the same time. The anesthetists used the same method, but had produced the different dermatome were blocked. The investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics to the anterior layer of thoracolumbar extrafascial, this produced the dermatomal coverage from lower abdominal to hip. A different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascia, the lower thoracic dermatome were blocked.

Detailed description: Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. But the lower thoracic to the hip dermatomes can't be blocked at the same time. The anesthetists used the same method, but had produced the different dermatomes were blocked. The investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics to the anterior thoracolumbar extrafascial (between the anterior layer of thoracolumbar fascia and psoas major muscle), this produced the dermatomal coverage from lower abdominal to hip. In this case, the investigators speculated the local anesthetic spread to the lumbar paravertebral space via the fascia and the fascicle of psoas major. A different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascial (between the anterior layer of thoracolumbar fascia and quadratus lumborum), the lower thoracic dermatomes were blocked. The investigators speculate that the local anesthetic injected subfascial could spread cephalad to lower thoracic paravertebral space posterior to the endothoracic fascia via lateral arcuate ligament.

The investigators confirm the hypothesis in the pilot trial. therefore, the investigators need to trial with large sample. The investigators plan to improve the clinical guidance of quadratus lumborum block technology, so that more patients benefit.

Eligibility criteria: Inclusion Criteria:

* Participants undergoing laparoscopic cholecystectomy. ASA: I\~II. BMI: 17\~32. The operation time is less than 2 hours. Participants volunteered for the trial.

Exclusion Criteria:

* Pregnant and lactation women. Coagulation disorders. Drug allergy. Can not communicate normally. Bacteremia. Emergency surgery. ASA: \>III.

Primary outcomes:
measure: Changes of pain intensity of the 3 holes at 48 hours post-operation
timeFrame: 48 hours after operation
Secondary outcomes:
measure: Adverse effects
timeFrame: 48 hours after operation
measure: Limbs weakness
timeFrame: at 30 min after block
measure: Postoperative analgesic consumption
timeFrame: 48 hours after operation
measure: dependent ambulation
timeFrame: at 1 and 6 hours after surgery
measure: Sensory block level
timeFrame: 30 min after blocked
measure: patients satisfaction
timeFrame: 48 hours after operation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First affiliated hospital of third military medical university
state: Chongqing
Study officials:
affiliation: First affiliation hospital of third military medical university
name: Kaizhi Lu, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: Kumar A, Sadeghi N, Wahal C, Gadsden J, Grant SA. Quadratus Lumborum Spares Paravertebral Space in Fresh Cadaver Injection. Anesth Analg. 2017 Aug;125(2):708-709. doi: 10.1213/ANE.0000000000002245. No abstract available.
citation: La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
citation: Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.