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Pain, PostoperativePhase 4NCT03294109

Evaluation of Abdominal Wall Block With Liposomal Bupivacaine for Post-Operative Analgesia in Donor Nephrectomy

A Phase 4 study testing Abdominal wall block with liposomal bupivicaine in people with Pain, Postoperative and Analgesics, Opioid, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A blinded randomized control trial in living kidney donors. The study group will receive a liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general anesthesia. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Abdominal wall block with liposomal bupivicaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to 24 Jun 2020
Phase
Phase 4
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 donor nephrectomy

Who cannot join

  • Pregnancy
  • Systemic or local infection at the potential block site.
  • Allergy or hypersensitivity to the local anesthetic,
  • Possible variations in surgical approach to donor nephrectomy other than what is defined in this protocol.
  • Scarring or anatomic abnormality over the proposed injection site

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Connie Frank Kidney Transplant Center

    Los Angeles, California, 90095

Other trials in United States

About this study

A blinded randomized control trial in living kidney donors. The study group will receive a liposomal bupivacaine Trans Quadratus Lumborum (TQL) block after the induction of general anesthesia. The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in Electronic Health Record (EHR). Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes.

Read the detailed description

This is a blinded (patients are blinded and all the staff and the nurses who collect data are also blinded) randomized controlled trial in living kidney donors who have been approved by a multidisciplinary (nephrology, urology, psychiatry, and social work) team to proceed with donor nephrectomy. Patients will be approached to participate in the study only after they have agreed to kidney donation and have been informed of all of the associated risks. Participants are informed that they can withdraw from kidney donation at any time until they are in the operating room.

Patients meeting these criteria, who also consent to participate in the study, will be randomized (standard of care pain medication vs TQL block). The ratio of male to female patients in each arm will be equal because of the known increased risks for post-operative nausea/vomiting (PONV) in females. The study group will receive a liposomal bupivacaine TQL block after the induction of general anesthesia and liposomal bupivacaine transverse abdominis plane (TAP) block after closure of the midline fascia. All patients including the control group will have infiltration of the skin edges with bupivacaine. Control patients will have a TAP block with 5 cc of bupivacaine on both sides. A placebo 22g needle will be placed at the same site as the TQL block without injection. Intra-operative narcotics will be administered by the anesthesia team based on standard criteria. All participants will receive intravenous ketorolac and acetaminophen at the end of the procedure. Intravenous ketorolac will be continued for 24 hours while hospitalized. Post-operative pain management with intermittent parenteral and enteral narcotics as needed will be the same in both groups.

Liposomal bupivacaine block administration:

After induction of general anesthesia, surgical team will turn the patient to the lateral position (final position for surgery). After prep with and drape, investigators will place ultrasound probe in mid- posterior axillary line, just above iliac crest. The investigators will identify abdominal wall muscles including external oblique, internal oblique, transverse abdominis, and quadratus lumborum as well as thoracolumbar fascia with the help of ultrasound. Then, investigators will insert a 22g nerve block needle and advanced it under direct guidance of ultrasound until it is below the fascial covering of the quadratus lumborum muscle layer or its fascia which forms a continuous fascia compartment with thoracolumbar fascia. After aspiration to rule out intravascular location of the needle, investigators will be inject 20 mL of liposomal bupivacaine mixed with 10ml of normal saline under ultrasound guidance, to monitor spread of the injected fluid . The investigators will aspirate repeatedly every 5cc of local anesthetic. The investigators will remove the needle upon completion of the injection.

The following study variables will be collected postoperatively following arrival in the post-anesthesia care unit. Current and maximum intensity pain scores will be documented by nurses in EHR. Total opiate dose consumed every 24 hours will be collected from the EHR and pain diary after discharge. Patient satisfaction will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) 24 hours' post-procedure. Incidence of nausea will be extracted from nursing notes

Complications will be documented by anesthesia pain service that will follow these patients while admitted.

Outpatient use of narcotics, pain assessment, bowel function, sexual function complications from the block or the donor surgery, and attitudes toward kidney donation will be evaluated with validated survey instruments. Please see the timeline for the collection of the data prior to and after kidney donation. The survey data will be collected using secure links to a REDCap server 3, 5, 10, 30, and 90 days after surgery.

Being tested
Abdominal wall block with liposomal bupivicaine
Keywords
TQL block, TAP block, donor nephrectomy, pain, patient satisfaction
Medical subject headings
Pain, Postoperative, Patient Satisfaction, Sexual Behavior, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal wall block with liposomal bupivicaineDrug

    Also called Exparel

    Abdominal wall block with liposomal bupivicaine

Study groups in NCT03294109
Study groupRoleWhat they receive
studyExperimentalliposomal bupivacain
Receives: Drug: Abdominal wall block with liposomal bupivicaine
controlNo interventionno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Score

    Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level

    Measured: 3 days post-op

Secondary outcomes (5)
  1. Patient Satisfaction With Pain Management

    The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey score on variable "Satisfaction with Pain Treatments." This is a scale ranging from 0-10, with 0 being extremely dissatisfied, a poor outcome, with pain treatment to 10 being extremely satisfied, a better outcome.

    Measured: Day 1

  2. Nausea and Vomiting, Defined as Requiring Pre-op Scopolamine Patch or Rescue Antiemetics

    Number of patients requiring pre-op scopolamine patch, and number of patients requiring rescue antiemetics in PACU.

    Measured: Day 1

  3. Return of Bowel Function

    Bowl activity survey asked participants how big a problem the bowel function was after surgery, on a scale of 1 (no problem) to 5 (a big problem).

    Measured: Day 5

  4. Participants Experiencing Complications Related to Surgery or Block

    Number of participants that experienced a related complication in each arm

    Measured: Duration of inpatient stay, up to 5 days

  5. Opioid Use Dose/Day

    Milligram Morphine Equivalent /day

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start1 Jan 2018
  3. Primary completion24 Jun 2020
  4. Study completion24 Jun 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294109
Sponsor's protocol ID
17-000598
Status last verified
Dec 2021
First submitted
18 Sep 2017
Last updated
10 Jan 2022
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.

    PubMed 27891579
  • Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.

    PubMed 28277325
  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

    PubMed 26225500
  • Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.

    PubMed 27429253
  • Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.

    PubMed 26771297
  • Gritsch HA, Osbun N, Grogan T, Fero KE, Partownavid P, Stockman J, Sadoughi N, Park E, Miller E, Blumberg J, McDonald M, Cowan N, Shah N, Rahman S. Randomized controlled trial of a quadratus lumborum block with liposomal bupivacaine for postoperative analgesia in laparoscopic donor nephrectomy. Clin Transplant. 2021 Sep;35(9):e14403. doi: 10.1111/ctr.14403. Epub 2021 Jul 14.

    PubMed 34184312

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abdominal wall block with liposomal bupivicaine in people with Pain, Postoperative and Analgesics, Opioid, run by University of California, Los Angeles 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 1 inclusion and 5 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 10 Jan 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2021). 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?

Change in Pain Score (time frame: 3 days post-op). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294109, which also lists 6 linked publications.

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 10 Jan 2022.

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