Clincosm LogoSign in Get a demo

Surgeon Infiltration QL Block Comparison

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03496610
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
23.2
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal Bupivicaine
  • Procedure: QL Block
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Quadratus Lumborum (QL) Block

Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.

Procedure: QL Block
Patient will receive ultrasound guided QL Block
Active Comparator: Surgical wound infiltration

Patients will receive 166 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.

Drug: Liposomal Bupivicaine
Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [Up to 7 days]

Secondary Outcome Measures

  1. Numeric pain scores as measured by the NRS 11 [Up to 7 days]

  2. Percentage of GI Complications [Up to 7 days]

  3. Physical activity after surgery as measured by walking test [Up to 7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • English speaking

  • ASA 1-2 patients undergoing living donor nephrectomy

Exclusion Criteria:

  • ASA 3 or 5

  • Diagnosis of chronic pain

  • Daily chronic opioid use (over 3 months of continuous opioid use)

  • Inability to communicate pain scores or need for analgesia

  • Infection at the site of block placement

  • Pregnant women (as determined by standard of care day-of surgery urine bHCG)

  • Intolerance/allergy to local anesthetics

  • Weight <50 kg

  • Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years

  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance

  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Hector Martinez-Wilson, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03496610
Other Study ID Numbers:
  • Pro00087144
First Posted:
Apr 12, 2018
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
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
Keywords provided by Duke University
Bupivacaine
Living donor nephrectomy
Additional relevant MeSH terms:
Surgical Wound
Bupivacaine

Study Results

No Results Posted as of Jan 19, 2022