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

B

Bruce Ben-David

Status and phase

Withdrawn
Phase 4

Conditions

Block
Postoperative Pain
Analgesia

Treatments

Drug: Ropivacaine 0.5% Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT04077398
STUDY19070444

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

low volume High concentration group
Experimental group
Description:
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
Treatment:
Drug: Ropivacaine 0.5% Injectable Solution
high volume low concentration
Experimental group
Description:
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
Treatment:
Drug: Ropivacaine 0.5% Injectable Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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