Volume vs Concentration: Quadratus Lumborum Blocks With High Volume/Low Concentration or Low Volume/ High Concentration in Nephrectomies

Postoperative Pain Clinical Trial

Official title:

Volume Versus Concentration: a Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Bilateral Quadratus Lumborum Blocks Using High Volume/Low Concentration or Low Volume/ High Concentration Local Anesthetic in Nephrectomies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04077398
• Other study ID #: STUDY19070444
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 22, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: February 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The quadratus lumborum has since 2016 become standard of care for abdominal and retroperitoneal surgeries at UPMC-Shadyside Hospital, replacing paravertebral blocks, and as part of a broader multimodal analgesia institutional Enhanced Recovery After surgery protocol. Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. What is proposed here is to investigate the relative clinical effectiveness of the relationship high volume/low concentration of local anesthetic or low volume/ high concentration of local anesthetic.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients 18-90 years old

2. Patients undergoing nephrectomy

3. Body Mass Index 19-36

4. Male and Female

5. All races

6. American Society of Anesthesiologist scale I, II, III

Exclusion Criteria:

1. Patient refusal

2. Pregnancy

3. Non-English speaking or inability to participate in the study

4. Patients with coagulopathy or With International Normalized Ratio >1,5 the day of the surgery.

5. Chronic steroid use

6. Chronic pain

7. Chronic opiate use

Related Conditions & MeSH terms

• Analgesia
• Block
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
There will be two groups, in order to compare two different sets of volumes with the same amount of drug. we will try to identify if it is better one volume over the other in terms of pain control and consume of opioids, as well the presence or absence of motor weakness.

Locations

Country	Name	City	State
United States	UPMC shadyside hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bruce Ben-David

Country where clinical trial is conducted

United States, 

References & Publications (1)

Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain control over the next 72 hours after surgery: Visual analogue scale	Visual analogue scale (0-10) measurement	72 hours
Secondary	opioid consumption during the first 72 hours	opioid consumption in morphine milliequivalents during the first 72 hours	72 hours
Secondary	time of the first opioid consumption after surgery	time after surgery that patient takes to require opioid medication after surgery	24 hours
Secondary	100 feet walking	time after surgery that the patient takes in order to be able to walk 100 feet	48 hours
Secondary	presence or absence of muscular weakness after Quadratus lumborum type 2 block	muscular weakness is associated sometime with femoral quadratus muscle weakness	24 hours