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NCT Number: NCT03421821

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First affiliated hospital of third military medical university

Chongqing, Chongqing Municipality, 400038, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Drug

Subfascial injection OR extrafascial injection

Other names: Naropin

Primary outcomes

  1. 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).

Secondary outcomes

  1. Adverse effects

    Time frame: 48 hours after operation

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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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