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

• Sponsor: Bruce Ben-David (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04077398
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia; Postoperative Pain; Block	Drug: Ropivacaine 0.5% Injectable Solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Randomization will be performed with software excel or spss. This randomization will be kept in an envelope. After the patient consents participation in the study, the investigator and the care provider will open the envelope and will perform the block according to the established in the randomization. The patient or the outcomes assessor will not have access to the volume and concentration used during the block. Will be the responsibility of investigators to keep in a safe place the information about the block received by the patients.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 22, 2020
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low volume High concentration group 1.Low Volume: 30 subjects randomized to Low Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,75% ropivacaine x 15 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg	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.
Experimental: high volume low concentration 2.High Volume: 30 subjects randomized to High Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,375% ropivacaine x 30 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg	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.

Outcome Measures

Primary Outcome Measures

1. pain control over the next 72 hours after surgery: Visual analogue scale [72 hours]

   Visual analogue scale (0-10) measurement

Secondary Outcome Measures

1. opioid consumption during the first 72 hours [72 hours]

   opioid consumption in morphine milliequivalents during the first 72 hours

2. time of the first opioid consumption after surgery [24 hours]

   time after surgery that patient takes to require opioid medication after surgery

3. 100 feet walking [48 hours]

   time after surgery that the patient takes in order to be able to walk 100 feet

4. presence or absence of muscular weakness after Quadratus lumborum type 2 block [24 hours]

   muscular weakness is associated sometime with femoral quadratus muscle weakness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC shadyside hospital	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Bruce Ben-David

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Bruce Ben-David, Clinical Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04077398
• Other Study ID Numbers: STUDY19070444
• First Posted: Sep 4, 2019
• Last Update Posted: Feb 16, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

No Results Posted as of Feb 16, 2021