Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study | Experimental | liposomal bupivacain |
|
| control | No Intervention | no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal wall block with liposomal bupivicaine | Drug | Abdominal wall block with liposomal bupivicaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level | 3 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Siamak Rahman, MD | University of California, Los Angeles | Principal Investigator |
| Hans a Gritsch, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connie Frank Kidney Transplant Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27891579 | Background | 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. | |
| 28277325 | Background | 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. |
| Label | URL |
|---|---|
| Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty | View source |
Not provided
Prior to randomization, 146 patients signed consent. Of those 146, 137 completed the intake questionnaire, a requirement for the study. Of those 137, 103 were scheduled for surgery.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Study | ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine: |
| FG001 | Control | ERAS Plus laparoscopic TAP block |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Day 1 |
| 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). | Day 5 |
| Participants Experiencing Complications Related to Surgery or Block | Number of participants that experienced a related complication in each arm | Duration of inpatient stay, up to 5 days |
| Opioid Use Dose/Day | Milligram Morphine Equivalent /day | Day 3 |
| 26225500 | Background | 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. |
| 27429253 | Background | 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. |
| 26771297 | Background | 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. |
| 34184312 | Derived | 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. |
| Underwent Surgery |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study | ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine |
| BG001 | Control | ERAS Plus laparoscopic TAP block |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Score | Visual Analog Score (VAS) for pain, scores range from 0-10, with lower scores indicating lower pain level | Participants who completed pain VAS survey on day 3 | Posted | Mean | Standard Deviation | score on a scale | 3 days post-op |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Patients who completed APS-POQ-R survey question "Satisfaction with Pain Treatments" on Day 1. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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). | Participants who completed the bowel activity survey on Day 5 | Posted | Mean | Standard Deviation | score on a scale | Day 5 |
|
| |||||||||||||||||||||||||||||
| Secondary | Participants Experiencing Complications Related to Surgery or Block | Number of participants that experienced a related complication in each arm | All enrolled patients receiving surgery | Posted | Count of Participants | Participants | Duration of inpatient stay, up to 5 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Opioid Use Dose/Day | Milligram Morphine Equivalent /day | Patients whom responded to survey on Day 3 | Posted | Count of Participants | Participants | Day 3 |
|
|
During hospitalization, up to 5 days
Complications from surgery were collected as adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine | 0 | 42 | 0 | 42 | 5 | 42 |
| EG001 | Control | ERAS Plus laparoscopic TAP block | 0 | 50 | 0 | 50 | 3 | 50 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Pleural Effusion requiring aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Incisional hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contralateral flank pain and acute kidney injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hypotension | Blood and lymphatic system disorders | Systematic Assessment | Post-operative hypotension in setting of acute blood loss |
| |
| Wound seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siamak Rahman, MD | university of Californiia | 310 2678839 | sirahman@mednet.ucla.edu |
| Jul 13, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D017060 | Patient Satisfaction |
| D012725 | Sexual Behavior |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|