Kidney DonorNCT03476850
Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy
A study testing QL Block and TAP Block in people with Kidney Donor, run by Medical University of South Carolina at 1 site in United States.
Trial summary
To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Donor
- What is being tested?
- QL Block and TAP Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 22 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic assisted donor nephrectomy
- Patients that have elected to have a nerve block
- 18 years of age or older
- Patients of ASA status I - III
Who cannot join
- Chronic pain or narcotic usage during the preceding 30 days
- Infection at or near the intended needle insertion site
- Complex or altered abdominal wall anatomy
- Weight <45kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.
- Conditions
- Kidney Donor
- Being tested
- QL Block, TAP Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL BlockProcedure or surgery
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
TAP BlockProcedure or surgery
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
| Study group | Role | What they receive |
|---|---|---|
| QL Block | Active comparator | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. Receives: Procedure: QL Block |
| TAP Block | Active comparator | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. Receives: Procedure: TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Score
NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative.
Measured: 24 hours post operative
Secondary outcomes (5)
Total Cumulative Opioids
opiate consumption first 72 hours post operatively
Measured: 72 hours
Number of Participants With Nausea or Emesis Requiring Antiemetic Medication
Antiemetics given in PACU. Occurrence of nausea or emesis requiring antiemetic medication administration in PACU.
Measured: 24 hours
Number of Participants With Block Related Complications
Measured: 24 hours
Length of Stay in Post Anesthesia Care Unit (PACU)
Duration of PACU stay.
Measured: 24 hours
Length of Hospital Stay
The time from surgery completion to subject meeting discharge criterion.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start19 Feb 2018
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney DonorStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Bolin, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476850
- Sponsor's protocol ID
- Pro00073925
- Status last verified
- Jun 2020
- First submitted
- 28 Feb 2018
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT03476850
- Acronym / sponsor ID
- Pro00073925
- Conditions
- Kidney Donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL Block | Active comparator | Procedure: QL BlockBlocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
| TAP Block | Active comparator | Procedure: TAP BlockBlocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing laparoscopic assisted donor nephrectomy
- Patients that have elected to have a nerve block
- 18 years of age or older
- Patients of ASA status I - III
Key exclusion criteria (4 listed)
- Chronic pain or narcotic usage during the preceding 30 days
- Infection at or near the intended needle insertion site
- Complex or altered abdominal wall anatomy
- Weight <45kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL BlockBlocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. | Procedure or surgery | QL Block |
| TAP BlockBlocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. | Procedure or surgery | TAP Block |
Primary outcome
Average Pain Score
Time frame: 24 hours post operative
NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative.
5 secondary outcomes
Total Cumulative Opioids
Time frame: 72 hours
Number of Participants With Nausea or Emesis Requiring Antiemetic Medication
Time frame: 24 hours
Number of Participants With Block Related Complications
Time frame: 24 hours
Length of Stay in Post Anesthesia Care Unit (PACU)
Time frame: 24 hours
Length of Hospital Stay
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Kidney Donor
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Active, not recruitingObservational study
Blood Biomarkers in Pediatric Kidney Transplant Recipients
Rejection of Kidney Allograft
Not yet recruitingPhase 1
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Not yet recruiting
Technology-enabled Social Network Intervention to Increase Live Donor Kidney Transplantation
End-Stage Renal Disease, Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL Block and TAP Block in people with Kidney Donor, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Score (time frame: 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.