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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03421821
Enrollment
80
Registered
2018-02-05
Start date
2018-02-25
Completion date
2018-09-17
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

quadratus lumborum block, anterior thoracolumbar fascia, subfascial injection, extrafascial injection

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.

Interventions

DRUGRopivacaine

Subfascial injection OR extrafascial injection

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

The investigators random divided subjects into two groups, the subfascial injection groupand the extrafascial injection group. Two groups were injected 0.33% ropivacaine 30 ml to the target location.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes of pain intensity of the 3 holes at 48 hours post-operation48 hours after operationThe 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

MeasureTime frameDescription
Limbs weaknessat 30 min after blockRecord 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 consumption48 hours after operationThe observer recorded the consumption of parecoxib sodium and fentanyl and the point of administered time within 48 hours after operation
Adverse effects48 hours after operationIncluded the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.
Sensory block level30 min after blockedThe sensory level was assessed with cold sensation (ice cube) in each dermatomal distribution from T4 to L5 every 5 minutes for 4 times.
patients satisfaction48 hours after operationPatient satisfaction was assessed using a scale of 0-10, 10 being the most satisfied, at postoperative 48 hours.
dependent ambulationat 1 and 6 hours after surgeryThe proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026