The Effects of Adding Dexamethasone in the Quadratus Lumborum Block

NCT04496193 | Unknown Phase 4

• 1 other identifier: KMUHIRB-F(I)-20200099
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The quadratus lumborum block is widely used in abdominal surgery for post-operative analgesia. It is now also used for pain relief after hip surgery. Under the traditional blocking method, a high concentration of long-acting local anesthetic is used in order to achieve a long-term blocking effect. However, this is also likely to cause the patient's quadriceps weakness during the block period, increasing the risk of the patient falling during rehabilitation. It also increases systemic local anesthetic poisoning and may even trigger the risk of serious side effects such as cardiac arrest. Ropivacaine is a novel long-acting topical amine anesthetics that lasts long and has anesthetic and analgesic effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor block separation at low concentrations more obvious, and with the external peripheral vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia. Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for tuberculosis patients. It is becoming more common to use steroids as an adjuvant to local anesthetics in peripheral nerve block. Steroids have neurological blockade effects by blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has also been widely studied recently. In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the quadratus lumborum block, reducing the local anesthetic concentration is a feasible method. However, this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative quadratus lumborum block with the addition of Dexamethasone 4mg to Ropivacaine (0.25%) in low concentrations and Ropivacaine (0.5%) alone.

Conditions

Analgesia; Motor Activity

Outcome Measures

Primary Outcomes (1)

• the post-operative analgesic effect of quadratus lumborum block

  1. The pain will be assessed using a 0 to 10 Numerical Rating Scale (NRS) 2. In an hour in the recovery room, the pain will be evaluated every 15 minutes. 3. Then the pain will be assessed at the 3rd, 6th, 12th, 24th, 36th, and 48th hours after surgery.

  Within 48 hours after surgery

Study Arms (3)

Group lower dose ropivacaine with dexamethasone

EXPERIMENTAL

Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + dexamethasone 0.8 ml (4mg) at the end of surgery

Procedure: Quadratus Lumborum block

Group higher dose ropivacaine with N/S

ACTIVE COMPARATOR

Quadratus lumborum block was administered with 0.5% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery

Procedure: Quadratus Lumborum block

Group lower dose ropivacaine with N/S

PLACEBO COMPARATOR

Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery

Procedure: Quadratus Lumborum block

Interventions

Quadratus Lumborum block PROCEDURE

Quadratus Lumborum block is a type of plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves.

Group higher dose ropivacaine with N/S; Group lower dose ropivacaine with N/S; Group lower dose ropivacaine with dexamethasone

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification: I \~ III
• Patients who received quadratus lumborum block for post-hip surgery analgesia

You may not qualify if:

• Lumbar plexus degeneration,
• Coagulation abnormalities with international normalized ratio (INR) \> 1.5
• Obvious heart, lung, liver or kidney disease
• Body mass index less than 18.5 or greater than 35
• Pregnancy
• Regular use of steroids or opiates Opioids
• Chronic medication or alcohol abuse
• Previous allergies or adverse reactions to opiates, dexamethasone, or ropivacaine

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Agnosia; Motor Activity

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hung-Te Hsu, MD, PhD

  Department of Anesthesiology, Kaohsiung Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Te Hsu, MD, PhD

CONTACT

+88673121101; hdhsu1228@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 3, 2020
• Study Start: July 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 4, 2020

Record last verified: 2020-06