ClinicalTrials.gg
CompletedNCT03421821Updated Feb 10, 2020

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

An interventional study of Ropivacaine in Postoperative Pain, sponsored by Third Military Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 184 studies testing ropivacaine in Pain, Postoperative — 20 open to participants now, 22 under way, 2 of them phase 3. Ropivacaine · Pain, Postoperative.

Enrollment
71st of 184
80 · median 70
Started
2018
with 11 others
No phase
61 of 184
8 open now
Registered
105th of 184
by date

Among the 184 studies testing ropivacaine in Pain, Postoperative, this one is the 71st largest by enrollment, is one of 12 that started in 2018, is one of 61 with no phase, and was the 105th registered.

By phase

184 studies; the count open now beside each. This study's row is marked.

Phase 484 · 7 open
No phasethis study61 · 8 open
Phase 323 · 0 open
Phase 210 · 3 open
Phase 14 · 1 open
Phase 1/21 · 0 open
Phase 2/31 · 1 open

By the year they started

First in 2003; this study’s year is marked. 12 started in 2018.

Size and results

Median enrollment 70 across the 184 interventional studies. Of the 125 that completed or were terminated, 32 (26%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 184 studies testing ropivacaine in Pain, Postoperative, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Postoperative Pain

Browse trials for

Keywords

  • quadratus lumborum block
  • anterior thoracolumbar fascia
  • subfascial injection
  • extrafascial injection
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant and lactation women. Coagulation disorders. Drug allergy. Can not communicate normally. Bacteremia. Emergency surgery. ASA: >III.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Subfascial Injection Group

    30 ml of 0.33% ropivacaine was injected to subfascial.

    Drug: Ropivacaine

  • Active comparator
    Extrafascial Injection Group

    30 ml of 0.33% ropivacaine was injected to extrafascial.

    Drug: Ropivacaine

Interventions

  • Subfascial injection OR extrafascial injection

    Also known as: Naropin

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 48 hours after operation

Secondary outcomes

  1. Adverse effects

    Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.

    Time frame: 48 hours after operation

  2. 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.

    Time frame: at 30 min after block

  3. Postoperative analgesic consumption

    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

  4. dependent ambulation

    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

  5. 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.

    Time frame: 30 min after blocked

  6. patients satisfaction

    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

07

Study locations

1 site
  • First affiliated hospital of third military medical university
    Chongqing, Chongqing 400038, China
08

References and documents

Publications

  • 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. PubMed 26225500 ↗
  • 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. PubMed 28802593 ↗
  • 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. PubMed 28654429 ↗
  • 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. PubMed 28036319 ↗
  • 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. PubMed 27891579 ↗

Individual participant data

Plan to share: Yes — De-identified individual participants data for all primary and secondary outcome measure will be made available.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03421821
Lead sponsor
Third Military Medical University
Responsible party
Wenquan He (Attending physician of anesthesiology department, Third Military Medical University) — Principal investigator
First posted
Feb 5, 2018
Start date
Feb 25, 2018
Primary completion
Sep 17, 2018
Completion
Sep 17, 2018
Last update
Feb 10, 2020

Study contacts

Kaizhi Lu, MD
study director · First affiliation hospital of third military medical university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ropivacaine

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