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

February 7, 2020 updated by: Wenquan He, Third Military Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • First affiliated hospital of third military medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 48 hours after operation
Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.
48 hours after operation
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.
at 30 min after block
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
48 hours after operation
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.
at 1 and 6 hours after surgery
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.
30 min after blocked
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.
48 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Study Director: Kaizhi Lu, MD, First affiliation hospital of third military medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2018

Primary Completion (Actual)

September 17, 2018

Study Completion (Actual)

September 17, 2018

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZK-HWQ1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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