The Difference Between the Extrafascial Injection and the Subfascial Injection of Quadratus Lumborum Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extrafascial Injection Versus Subfascial Injection of Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators random divided subjects into two groups, the subfascial injection groupand the extrafascial injection group. Two groups were injected 0.33% ropivacaine 30 ml to the target location.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subfascial Injection Group<br>30 ml of 0.33% ropivacaine was injected to subfascial. | Drug: Ropivacaine<br>* Subfascial injection OR extrafascial injection<br>* Other names: Naropin;|
| Active Comparator: Extrafascial Injection Group<br>30 ml of 0.33% ropivacaine was injected to extrafascial. | Drug: Ropivacaine<br>* Subfascial injection OR extrafascial injection<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of pain intensity of the 3 holes at 48 hours post-operation | The three holes include the Subxiphoid hole, Subcostal hole and supraumbilical hole in the laparoscopic cholecystectomy. Patients reported pain intensity of each hole in the post-operation of 1 hour, 6 hours, 12 hours, 24 hours, 36 hours and 48 hours. Each item is scored 0-10 (0 = no pain; 10= pain as bad as can be). | 48 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity. | 48 hours after operation | 
| Limbs weakness | Record according to the modified Lovett rating scale (LRS). It was defined as follows: 0 = complete paralysis; 1 = almost complete paralysis; 2 = pronounced mobility impairment; 3 = slightly impaired mobility; 4 = pronounced reduction of muscular force; 5 = slightly reduced muscular force; 6 = normal muscular force. | at 30 min after block | 
| Postoperative analgesic consumption | The observer recorded the consumption of parecoxib sodium and fentanyl and the point of administered time within 48 hours after operation | 48 hours after operation | 
| dependent ambulation | The proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups. | at 1 and 6 hours after surgery | 
| Sensory block level | The sensory level was assessed with cold sensation (ice cube) in each dermatomal distribution from T4 to L5 every 5 minutes for 4 times. | 30 min after blocked | 
| patients satisfaction | Patient satisfaction was assessed using a scale of 0-10, 10 being the most satisfied, at postoperative 48 hours. | 48 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadratus lumborum block, anterior thoracolumbar fascia, subfascial injection, extrafascial injection