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

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ClinicalTrials.gov Identifier: NCT03421821
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Wenquan He, Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extrafascial Injection Versus Subfascial Injection of Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
Actual Study Start Date : February 25, 2018
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subfascial Injection Group
30 ml of 0.33% ropivacaine was injected to subfascial.
Drug: Ropivacaine
Subfascial injection OR extrafascial injection
Other Name: Naropin

Active Comparator: Extrafascial Injection Group
30 ml of 0.33% ropivacaine was injected to extrafascial.
Drug: Ropivacaine
Subfascial injection OR extrafascial injection
Other Name: Naropin




Primary Outcome Measures :
  1. Changes of pain intensity of the 3 holes at 48 hours post-operation [ Time Frame: 48 hours after 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).


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: 48 hours after operation ]
    Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.

  2. Limbs weakness [ Time Frame: at 30 min after block ]
    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.

  3. Postoperative analgesic consumption [ Time Frame: 48 hours after operation ]
    The observer recorded the consumption of parecoxib sodium and fentanyl and the point of administered time within 48 hours after operation

  4. dependent ambulation [ Time Frame: at 1 and 6 hours after surgery ]
    The proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups.

  5. Sensory block level [ Time Frame: 30 min after blocked ]
    The sensory level was assessed with cold sensation (ice cube) in each dermatomal distribution from T4 to L5 every 5 minutes for 4 times.

  6. patients satisfaction [ Time Frame: 48 hours after operation ]
    Patient satisfaction was assessed using a scale of 0-10, 10 being the most satisfied, at postoperative 48 hours.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421821


Locations
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China, Chongqing
First affiliated hospital of third military medical university
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Third Military Medical University
Investigators
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Study Director: Kaizhi Lu, MD First affiliation hospital of third military medical university
Publications of Results:
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Responsible Party: Wenquan He, Attending physician of anesthesiology department, Third Military Medical University
ClinicalTrials.gov Identifier: NCT03421821    
Other Study ID Numbers: MZK-HWQ1
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participants data for all primary and secondary outcome measure will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Wenquan He, Third Military Medical University:
quadratus lumborum block
anterior thoracolumbar fascia
subfascial injection
extrafascial injection
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents