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Postoperative PainNCT03421821

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

A study testing Ropivacaine in people with Postoperative Pain, run by Third Military Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
25 Feb 2018to 17 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pregnant and lactation women. Coagulation disorders. Drug allergy. Can not communicate normally. Bacteremia. Emergency surgery. ASA: >III.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First affiliated hospital of third military medical university

    Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

Official title: 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.

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.

Being tested
Ropivacaine
Keywords
quadratus lumborum block, anterior thoracolumbar fascia, subfascial injection, extrafascial injection
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called Naropin

    Subfascial injection OR extrafascial injection

Study groups in NCT03421821
Study groupRoleWhat they receive
Subfascial Injection GroupExperimental30 ml of 0.33% ropivacaine was injected to subfascial.
Receives: Drug: Ropivacaine
Extrafascial Injection GroupActive comparator30 ml of 0.33% ropivacaine was injected to extrafascial.
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 48 hours after operation

Secondary outcomes (6)

  1. Adverse effects

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

    Measured: 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.

    Measured: 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

    Measured: 48 hours after operation

  4. dependent ambulation

    The proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups.

    Measured: 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.

    Measured: 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.

    Measured: 48 hours after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start25 Feb 2018
  3. Primary completion17 Sep 2018
  4. Study completion17 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03421821
Sponsor's protocol ID
MZK-HWQ1
Status last verified
Feb 2020
First submitted
22 Jan 2018
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participants data for all primary and secondary outcome measure will be made available.

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

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine in people with Postoperative Pain, run by Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of pain intensity of the 3 holes at 48 hours post-operation (time frame: 48 hours after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03421821, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.

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Clinical Trial NCT03421821 | AzTrials