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

NCT03421821 | Completed DMC

• 1 other identifier: MZK-HWQ1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

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

Outcome Measures

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).

  48 hours after operation

Secondary Outcomes (6)

• Adverse effects

  48 hours after operation

• Limbs weakness

  at 30 min after block

• Postoperative analgesic consumption

  48 hours after operation

• dependent ambulation

  at 1 and 6 hours after surgery

• Sensory block level

  30 min after blocked

Study Arms (2)

Subfascial Injection Group

EXPERIMENTAL

30 ml of 0.33% ropivacaine was injected to subfascial.

Drug: Ropivacaine

Extrafascial Injection Group

ACTIVE COMPARATOR

30 ml of 0.33% ropivacaine was injected to extrafascial.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Subfascial injection OR extrafascial injection

Also known as: Naropin

Extrafascial Injection Group; Subfascial Injection Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

First affiliated hospital of third military medical university

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (5)

• 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.

  PMID: 26225500 RESULT

• 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.

  PMID: 28802593 RESULT

• 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.

  PMID: 28654429 RESULT

• 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.

  PMID: 28036319 RESULT

• 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.

  PMID: 27891579 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kaizhi Lu, MD

  First affiliation hospital of third military medical university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of anesthesiology department

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 5, 2018
• Study Start: February 25, 2018
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

CN (1)