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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Ropivacaine

• Registration Number: NCT03421821
• Lead Sponsor: Third Military Medical University

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.

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-05
• Study Start: 2018-02-25
• Primary Completion: 2018-09-17
• Study Completion: 2018-09-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extrafascial Injection Group	Ropivacaine	30 ml of 0.33% ropivacaine was injected to extrafascial.
Subfascial Injection Group	Ropivacaine	30 ml of 0.33% ropivacaine was injected to subfascial.

Primary Outcome Measures

Name	Time	Method
Changes of pain intensity of the 3 holes at 48 hours post-operation	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 Outcome Measures

Name	Time	Method
patients satisfaction	48 hours after operation	Patient satisfaction was assessed using a scale of 0-10, 10 being the most satisfied, at postoperative 48 hours.
Adverse effects	48 hours after operation	Included the Postoperative nausea and vomiting (PONV),pruritus, gastroduodenal ulcer and local anaesthetics toxicity.
Postoperative analgesic consumption	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
dependent ambulation	at 1 and 6 hours after surgery	The proportion of dependent ambulation assistance at 1 and 6 hours after surgery in the two groups.
Sensory block level	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.
Limbs weakness	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.

Trial Locations

Locations (1)

First affiliated hospital of third military medical university; 🇨🇳 Chongqing, Chongqing, China