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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring quadratus lumborum block, anterior thoracolumbar fascia, subfascial injection, extrafascial injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • First affiliated hospital of third military medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subfascial Injection Group

Extrafascial Injection Group

Arm Description

30 ml of 0.33% ropivacaine was injected to subfascial.

30 ml of 0.33% ropivacaine was injected to extrafascial.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Adverse effects
Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.
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.
Postoperative analgesic consumption
The observer recorded the consumption of parecoxib sodium and fentanyl and the point of administered time within 48 hours after operation
dependent ambulation
The proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups.
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.
patients satisfaction
Patient satisfaction was assessed using a scale of 0-10, 10 being the most satisfied, at postoperative 48 hours.

Full Information

First Posted
January 22, 2018
Last Updated
February 7, 2020
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03421821
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 25, 2018 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
quadratus lumborum block, anterior thoracolumbar fascia, subfascial injection, extrafascial injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subfascial Injection Group
Arm Type
Experimental
Arm Description
30 ml of 0.33% ropivacaine was injected to subfascial.
Arm Title
Extrafascial Injection Group
Arm Type
Active Comparator
Arm Description
30 ml of 0.33% ropivacaine was injected to extrafascial.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Subfascial injection OR extrafascial injection
Primary Outcome Measure Information:
Title
Changes of pain intensity of the 3 holes at 48 hours post-operation
Description
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).
Time Frame
48 hours after operation
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.
Time Frame
48 hours after operation
Title
Limbs weakness
Description
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.
Time Frame
at 30 min after block
Title
Postoperative analgesic consumption
Description
The observer recorded the consumption of parecoxib sodium and fentanyl and the point of administered time within 48 hours after operation
Time Frame
48 hours after operation
Title
dependent ambulation
Description
The proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups.
Time Frame
at 1 and 6 hours after surgery
Title
Sensory block level
Description
The sensory level was assessed with cold sensation (ice cube) in each dermatomal distribution from T4 to L5 every 5 minutes for 4 times.
Time Frame
30 min after blocked
Title
patients satisfaction
Description
Patient satisfaction was assessed using a scale of 0-10, 10 being the most satisfied, at postoperative 48 hours.
Time Frame
48 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaizhi Lu, MD
Organizational Affiliation
First affiliation hospital of third military medical university
Official's Role
Study Director
Facility Information:
Facility Name
First affiliated hospital of third military medical university
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participants data for all primary and secondary outcome measure will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a data access agreement.
Citations:
PubMed Identifier
26225500
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.
Results Reference
result
PubMed Identifier
28802593
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.
Results Reference
result
PubMed Identifier
28654429
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.
Results Reference
result
PubMed Identifier
28036319
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.
Results Reference
result
PubMed Identifier
27891579
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.
Results Reference
result

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

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