Pain, PostoperativePhase 3NCT04426500
Use of Perioperative Pain Blocks In Urological Surgery
A Phase 3 study testing Bupivacain, Ultrasound-guided transversus abdominus plane block and Laparoscopic-guided transversus abdominus plane block in people with Pain, Postoperative and Nerve Block, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Nerve Block, Robotic Surgical Procedures
- What is being tested?
- Bupivacain, Ultrasound-guided transversus abdominus plane block and Laparoscopic-guided transversus abdominus plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 13 Feb 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing Robotic Assisted Laparoscopic Partial Nephrectomy or Robotic Assisted Laparoscopic Prostatectomy
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Prior Partial Nephrectomy or Subtotal Prostatectomy Surgery (organ specific)
- Conversion to open surgery
- History of chronic pain
- History of opiate or alcohol dependence
- Allergies to local anesthetic
- Retroperitoneal surgery
- Single Port Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial
The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
Read the detailed description
Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic blocks) are being employed for the care of urological surgery patients. Local and regional anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be challenging, particularly in larger, obese patients. It is unknown how such techniques compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall, potentially allowing for greater ease of access from a laparoscopic approach from within than the ultrasound guided percutaneous approach.
Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15) vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014 compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with decreased accrual secondary to a surgeon taking a leave of absence during the study period. Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2) vs. 4 (2-6)) on the VAS score, respectively.
A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).
The most recent study, done in 2018, examined 100 randomized patients undergoing robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).
While all of these studies point to potential efficacy of UTAP, no data has been published to date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided administration. While these regional anesthetic blocks carry a theoretical risk of hematoma or damage to surrounding structures, none of the above studies report any complications with the injections.
The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
- Being tested
- Bupivacain, Ultrasound-guided transversus abdominus plane block, Laparoscopic-guided transversus abdominus plane block
- Keywords
- Phase III, Randomized, Single blind, Single Center, Three arm, Non-inferiority
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Local anesthesia
Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane blockDrug
Also called UTAP
bilateral TAP using ultrasound guidance in prostatectomies
Laparoscopic-guided transversus abdominus plane blockDrug
Also called LTAP
bilateral TAP using laparoscopic guidance in prostatectomies
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Local Anesthesia | Placebo comparator | Direct injection of 0.25% bupivacaine into surgical wounds Receives: Drug: Bupivacain |
| Ultrasound-guided transversus abdominus plane (UTAP) block | Active comparator | 30mL of 0.25% bupivacaine will be administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). Receives: Drug: Bupivacain; Drug: Ultrasound-guided transversus abdominus plane block |
| Laparoscopic-guided transversus abdominus plane (LTAP) block | Experimental | 30mL of 0.25% bupivacaine will be administered to bilateral TAP using laparoscopic guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). Receives: Drug: Bupivacain; Drug: Laparoscopic-guided transversus abdominus plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain
Measured: 24 hours post operatively
Secondary outcomes (10)
Intraoperative Time and Block Time
Intraoperative time taken to complete surgical blocks and operative
Measured: up to 420 minutes
Intraoperative Narcotic Use
Intraoperative Narcotic Use in morphine equivalents
Measured: up to 420 minutes
Intraoperative Ketoralac Use
Intraoperative Ketoralac Use
Measured: up to 420 minutes
Postoperative Narcotic Use
Postoperative Narcotic Use in morphine equivalents
Measured: 24 hours post operatively
Total Analgesic Medications
The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.
Measured: 24 hours post operatively
The Amount of Ondansetron Use
Use of antiemetic medications during the postoperative course
Measured: 2 weeks
Number of Days to Return of Bowel Function
Number of days to the return of bowel function
Measured: 2 weeks
The Length of Hospital Stay
Length of hospital stay from time of surgical completion to time of discharge.
Measured: 2 weeks
VAS in Obese Patients
24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI >30 and BMI<30
Measured: 24 hours post operatively
Number of Procedure Related Complications
Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start11 Nov 2019
- Primary completion13 Feb 2021
- Study completion13 Feb 2021
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 (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, single-blinded, (stratified) randomized placebo-controlled three-arm non-inferiority trial with 2:2:1 allocation ratio. People who meet eligibility requirements and provide informed consent will be randomly allocated to 3 groups to receive either UTAP, LTAP or Placebo with a 2:2:1 allocation ratio. The allocation sequence will be stratified by type of surgery (prostatectomy or partial nephrectomy) using stratified block randomization with randomly varying block sizes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias. Investigators will be blinded to the size of each block with only the study statistician responsible for generating the randomization list knowing this information.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Mehrazin, Icahn School of Medicine at Mount Sinai
- Investigators
- Reza Mehrazin, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426500
- Sponsor's protocol ID
- GCO 19-1532
- Other IDs
- NCI-2019-08790
- Status last verified
- Feb 2024
- First submitted
- 8 Jun 2020
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.
PubMed 22902793Aniskevich S, Taner CB, Perry DK, Robards CB, Porter SB, Thomas CS, Logvinov II, Clendenen SR. Ultrasound-guided transversus abdominis plane blocks for patients undergoing laparoscopic hand-assisted nephrectomy: a randomized, placebo-controlled trial. Local Reg Anesth. 2014 May 25;7:11-6. doi: 10.2147/LRA.S61589. eCollection 2014.
PubMed 24860252Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4.
PubMed 27733219Dal Moro F, Aiello L, Pavarin P, Zattoni F. Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study. J Robot Surg. 2019 Feb;13(1):147-151. doi: 10.1007/s11701-018-0858-6. Epub 2018 Jul 28.
PubMed 30056612
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04426500
- Acronym / sponsor ID
- GCO 19-1532
- Keywords
- Phase III, Randomized, Single blind, Single Center, Three arm, Non-inferiority
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 13 Feb 2021 (actual)
- Study completion
- 13 Feb 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 6 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
Detailed description
Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic blocks) are being employed for the care of urological surgery patients. Local and regional anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be challenging, particularly in larger, obese patients. It is unknown how such techniques compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall, potentially allowing for greater ease of access from a laparoscopic approach from within than the ultrasound guided percutaneous approach.
Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15) vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014 compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with decreased accrual secondary to a surgeon taking a leave of absence during the study period. Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2) vs. 4 (2-6)) on the VAS score, respectively.
A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).
The most recent study, done in 2018, examined 100 randomized patients undergoing robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).
While all of these studies point to potential efficacy of UTAP, no data has been published to date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided administration. While these regional anesthetic blocks carry a theoretical risk of hematoma or damage to surrounding structures, none of the above studies report any complications with the injections.
The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a single-center, single-blinded, (stratified) randomized placebo-controlled three-arm non-inferiority trial with 2:2:1 allocation ratio. People who meet eligibility requirements and provide informed consent will be randomly allocated to 3 groups to receive either UTAP, LTAP or Placebo with a 2:2:1 allocation ratio. The allocation sequence will be stratified by type of surgery (prostatectomy or partial nephrectomy) using stratified block randomization with randomly varying block sizes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias. Investigators will be blinded to the size of each block with only the study statistician responsible for generating the randomization list knowing this information.
| Arm | Type | Receives |
|---|---|---|
| Placebo/Local Anesthesia | Placebo comparator | Drug: BupivacainDirect injection of 0.25% bupivacaine into surgical wounds |
| Ultrasound-guided transversus abdominus plane (UTAP) block | Active comparator | Drug: Bupivacain, Drug: Ultrasound-guided transversus abdominus plane block30mL of 0.25% bupivacaine will be administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). |
| Laparoscopic-guided transversus abdominus plane (LTAP) block | Experimental | Drug: Bupivacain, Drug: Laparoscopic-guided transversus abdominus plane block30mL of 0.25% bupivacaine will be administered to bilateral TAP using laparoscopic guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Undergoing Robotic Assisted Laparoscopic Partial Nephrectomy or Robotic Assisted Laparoscopic Prostatectomy
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (7 listed)
- Prior Partial Nephrectomy or Subtotal Prostatectomy Surgery (organ specific)
- Conversion to open surgery
- History of chronic pain
- History of opiate or alcohol dependence
- Allergies to local anesthetic
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 |
|---|---|---|
| BupivacainAlso: Local anesthesiaDirect injection of 0.25% bupivacaine into surgical wounds | Drug | Laparoscopic-guided transversus abdominus plane (LTAP) block, Placebo/Local Anesthesia, Ultrasound-guided transversus abdominus plane (UTAP) block |
| Ultrasound-guided transversus abdominus plane blockAlso: UTAPbilateral TAP using ultrasound guidance in prostatectomies | Drug | Ultrasound-guided transversus abdominus plane (UTAP) block |
| Laparoscopic-guided transversus abdominus plane blockAlso: LTAPbilateral TAP using laparoscopic guidance in prostatectomies | Drug | Laparoscopic-guided transversus abdominus plane (LTAP) block |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 24 hours post operatively
Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain
10 secondary outcomes
Intraoperative Time and Block Time
Time frame: up to 420 minutes
Intraoperative Narcotic Use
Time frame: up to 420 minutes
Intraoperative Ketoralac Use
Time frame: up to 420 minutes
Postoperative Narcotic Use
Time frame: 24 hours post operatively
Total Analgesic Medications
Time frame: 24 hours post operatively
The Amount of Ondansetron Use
Time frame: 2 weeks
Number of Days to Return of Bowel Function
Time frame: 2 weeks
The Length of Hospital Stay
Time frame: 2 weeks
VAS in Obese Patients
Time frame: 24 hours post operatively
Number of Procedure Related Complications
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22902793Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.
- Background: PubMed 24860252Aniskevich S, Taner CB, Perry DK, Robards CB, Porter SB, Thomas CS, Logvinov II, Clendenen SR. Ultrasound-guided transversus abdominis plane blocks for patients undergoing laparoscopic hand-assisted nephrectomy: a randomized, placebo-controlled trial. Local Reg Anesth. 2014 May 25;7:11-6. doi: 10.2147/LRA.S61589. eCollection 2014.
- Background: PubMed 27733219Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4.
- Background: PubMed 30056612Dal Moro F, Aiello L, Pavarin P, Zattoni F. Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study. J Robot Surg. 2019 Feb;13(1):147-151. doi: 10.1007/s11701-018-0858-6. Epub 2018 Jul 28.
- Individual participant dataSharing planned: No
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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.
Reza Mehrazin, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacain, Ultrasound-guided transversus abdominus plane block and Laparoscopic-guided transversus abdominus plane block in people with Pain, Postoperative and Nerve Block, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 7 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 12 Mar 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 May 2022). 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?
Visual Analog Scale (VAS) (time frame: 24 hours post operatively). 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 NCT04426500, which also lists 4 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 12 Mar 2024.