Vaginal HysterectomyPhase 4NCT03907033

Liposomal Bupivacaine in Vaginal Hysterectomy

A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Vaginal Hysterectomy, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 years, women only
Conditions the study is for: Vaginal Hysterectomy
What is being tested?: Liposomal bupivacaine and Bupivacaine Hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 3 Sep 2019to 23 Jul 2021
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 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

Who cannot join

Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
Known history of prolonged QT (QTc greater than 500 m/s)
Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron
Allergy to both oxycodone and hydromorphone
Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment
Adults lacking the ability to consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Arizona
Phoenix, Arizona, 85054

Other trials in United States

About this study

Official title: Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study

The aim of this study is to compare the effects of preemptive analgesia using liposomal bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament injection in patients undergoing vaginal hysterectomy. We hypothesize that the group receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior postoperative pain management. Enhancement in pain control should confer a decrease in opioid and other analgesic medication requirements, which may contribute to decreased nausea, vomiting, and higher overall patient satisfaction with pain control.

Read the detailed description

Prior to surgery, patients are assigned by chance (like a coin toss) to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine. Patients and the Principal Investigator cannot choose the study group. Patients will have a 50% chance of being assigned to either group; however, regardless of which group they are assigned to, the medical record will show that they received liposomal bupivacaine. The injections will be given in the vaginal area when the patient is under anesthesia.

After surgery, patients will be asked to record their pain, medication use, pain scores and symptoms in a diary for each 12 hour interval up to 72 hours. Someone will also call twice a day during the 72 hours after surgery to ask about pain level and pain medication use.

Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level.

Conditions: Vaginal Hysterectomy
Being tested: Liposomal bupivacaine, Bupivacaine Hydrochloride

What participants receive

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

Liposomal bupivacaineDrug
Also called Exparel
Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine HydrochlorideDrug
We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.

Study groups in NCT03907033
Study group	Role	What they receive
Standard Bupivacaine	Active comparator	Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments. Receives: Drug: Bupivacaine Hydrochloride
Liposomal Bupivacaine	Experimental	Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

What is being measured

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

Total Post-surgical Opioid Medication Use
Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)
Measured: First 72 hours following surgery completion
Total Post-surgical Analgesic Medication Use
Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)
Measured: First 72 hours following surgery completion

Secondary outcomes (6)

Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score
Scale Ranges from 0 (no pain) to 10 (extreme pain)
Measured: Assessed while patient in PACU for recovery post-surgery per standard procedure
VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion
Scale Ranges from 0 (no pain) to 10 (extreme pain)
Measured: 24, 48, and 72 hours post-surgery completion
Nausea at 24, 48, and 72 Hours Post-surgery Completion
Number of times patient reported feeling nauseous
Measured: 24, 48, and 72 hours post-surgery
Emesis at 24, 48, and 72 Hours Post-surgery Completion
Number of times the patient vomited
Measured: 24, 48, and 72 hours post-surgery
Urinary Retention
Number of patients who had post-void residual (PVR) >150cc's at voiding trial prior to discharge
Measured: At voiding trial prior to discharge from hospital, approximately 72 hours
Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery
Assessed on 0-10 scale (0 being worst level of satisfaction, 10 being best level)
Measured: 72 hours and 7-10 days post surgery

Timeline

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

3 Sep 201923 Jul 2021

First posted8 Apr 2019
Study start3 Sep 2019
Primary completion23 Jul 2021
Study completion23 Jul 2021

Why it stopped: Insufficient funding to continue with study activities

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.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Vaginal HysterectomyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be randomized to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03907033
Sponsor's protocol ID: 15-008413
Status last verified: Sep 2021
First submitted: 5 Apr 2019
Last updated: 15 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.
PubMed 18830553
Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
PubMed 26204387
Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
PubMed 22570563
Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
PubMed 26056753
Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
PubMed 28802777
Kalogera E, Bakkum-Gamez JN, Jankowski CJ, Trabuco E, Lovely JK, Dhanorker S, Grubbs PL, Weaver AL, Haas LR, Borah BJ, Bursiek AA, Walsh MT, Cliby WA, Dowdy SC. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-328. doi: 10.1097/AOG.0b013e31829aa780.
PubMed 23969801

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Recruiting
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
Prolapse Pelvic, Hysterectomy
Recruiting
Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
Hysterectomy, Vaginal
Recruiting
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Hysterectomy, Benign Uterine Diseases

All Vaginal Hysterectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT03907033
Acronym / sponsor ID: 15-008413
Conditions: Vaginal Hysterectomy
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient funding to continue with study activities
Enrolment: 28 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Pacira Pharmaceuticals, Inc
Study start: 3 Sep 2019 (actual)
Primary completion: 23 Jul 2021 (actual)
Study completion: 23 Jul 2021 (actual)
First posted: 8 Apr 2019 (actual)
Results: Posted 15 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Patients will be randomized to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine.

Arm	Type	Receives
Standard Bupivacaine	Active comparator	Drug: Bupivacaine HydrochloridePatients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Liposomal Bupivacaine	Experimental	Drug: Liposomal bupivacaine, Drug: Bupivacaine HydrochloridePatients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments

Who may qualify

Ages: 18 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

Key exclusion criteria (8 listed)

Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
Known history of prolonged QT (QTc greater than 500 m/s)
Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron

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
Liposomal bupivacaineAlso: ExparelLiposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.	Drug	Liposomal Bupivacaine
Bupivacaine HydrochlorideWe currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.	Drug	Liposomal Bupivacaine, Standard Bupivacaine

Primary outcome

Total Post-surgical Opioid Medication Use
Time frame: First 72 hours following surgery completion
Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)
Total Post-surgical Analgesic Medication Use
Time frame: First 72 hours following surgery completion
Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)

6 secondary outcomes

Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score
Time frame: Assessed while patient in PACU for recovery post-surgery per standard procedure
VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion
Time frame: 24, 48, and 72 hours post-surgery completion
Nausea at 24, 48, and 72 Hours Post-surgery Completion
Time frame: 24, 48, and 72 hours post-surgery
Emesis at 24, 48, and 72 Hours Post-surgery Completion
Time frame: 24, 48, and 72 hours post-surgery
Urinary Retention
Time frame: At voiding trial prior to discharge from hospital, approximately 72 hours
Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery
Time frame: 72 hours and 7-10 days post surgery

Results and safety

Results posted to the registry on 15 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Bupivacaine	14	14
Liposomal Bupivacaine	14	14

Primary outcome: Total Post-surgical Opioid Medication Use

Time frame: First 72 hours following surgery completion. Median (Full Range). Unit: Morphine Equivalents (ME)

Measure	Standard Bupivacaine n = 14	Liposomal Bupivacaine n = 14
Hydrocodone	0 (0.0 to 0.0)	0 (0.0 to 0.0)
Oxycodone	30.0 (0.0 to 82.5)	30.0 (0.0 to 135.0)

Standard Bupivacaine vs Liposomal Bupivacaine: p = 1.000, Wilcoxon (Mann-Whitney)
Standard Bupivacaine vs Liposomal Bupivacaine: p = 0.010, Wilcoxon (Mann-Whitney)

Primary outcome: Total Post-surgical Analgesic Medication Use

Time frame: First 72 hours following surgery completion. Median (Full Range). Unit: mg

Measure	Standard Bupivacaine n = 14	Liposomal Bupivacaine n = 14
Ibuprofen	5400.0 (3000.0 to 13200.0)	4800.0 (0.0 to 13200.00)
Tylenol	6500.0 (0.0 to 13000.0)	6500.0 (500.0 to 13000.0)

Standard Bupivacaine vs Liposomal Bupivacaine: p = 0.248, Wilcoxon (Mann-Whitney)
Standard Bupivacaine vs Liposomal Bupivacaine: p = 1.000, Wilcoxon (Mann-Whitney)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected post operative on all participants, approximately 7 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Bupivacaine	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
Liposomal Bupivacaine	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18830553Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.
Background: PubMed 26204387Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
Background: PubMed 22570563Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
Background: PubMed 26056753Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
Background: PubMed 28802777Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
Background: PubMed 23969801Kalogera E, Bakkum-Gamez JN, Jankowski CJ, Trabuco E, Lovely JK, Dhanorker S, Grubbs PL, Weaver AL, Haas LR, Borah BJ, Bursiek AA, Walsh MT, Cliby WA, Dowdy SC. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-328. doi: 10.1097/AOG.0b013e31829aa780.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Vaginal Hysterectomy

RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Recruiting
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
Prolapse Pelvic, Hysterectomy
Recruiting
Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
Hysterectomy, Vaginal
Recruiting
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Hysterectomy, Benign Uterine 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.

Jeffrey L Cornella principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Vaginal Hysterectomy, run by Mayo Clinic 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 8 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: stopped early, as of the sponsor's last update on 15 Oct 2021. 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 15 Oct 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?

Total Post-surgical Opioid Medication Use (time frame: First 72 hours following surgery completion). The study lists 2 primary outcomes in all. 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 NCT03907033, 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 15 Oct 2021.