Prostate CancerPhase 1NCT04470843
Impact of Acetazolamide in Reducing Referred Postoperative Pain
A Phase 1 study testing Acetazolamide in people with Prostate Cancer and Men, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves removing a man's prostate using a minimally invasive robotic approach under the guidance of a surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Men
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2018to 31 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients ≥18 years of age undergoing robotic-assisted prostatectomy
Who cannot join
- Patients with renal insufficiency with serum creatinine >2.0 mg/dl
- Patients with renal transplant
- Patients with pre-existing metabolic acidosis
- Patients with chronic obstructive pulmonary disease
- Patients with hepatic disease
- Patients with central nervous system disorders
Show all 12Show fewer
- Patients with hematological disease history
- Patients with pre-existing electrolyte abnormalities
- Patients with hypovolemia
- Patients with lithium or diuretic usage
- Patients with sulfonamides allergy
- Patients with American Society of Anesthesiologists physical status 4 or 5
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Impact of Acetazolamide in Reducing Referred Postoperative Pain After Robotic Assisted Laparoscopic Prostatectomy
Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves removing a man's prostate using a minimally invasive robotic approach under the guidance of a surgeon. In order to gain sufficient access, carbon dioxide (CO2) is used to fill the surgical space in a process termed insufflation. Carbon dioxide is a mainstay in laparoscopic procedures because it is cost-effective, noncombustible and readily excreted via the respiratory system in healthy patients.
Insufflation with CO2, however, has been linked to post-operative referred pain secondary to peritoneal acidosis.This acidosis is suspected to be due to the formation of carbonic acid from the CO2 insufflation.Peritoneal acidosis, and its associated post-operative referred pain, may not be adequately treated with the current standard pain control regimen.
- Conditions
- Prostate Cancer, Men
- Being tested
- Acetazolamide, Placebo
- Keywords
- Prostatectomy, Acetazolamide, Postoperative Pain, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Multiple Endocrine Neoplasia Type 1, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Being that adequate pain control is essential to recovery in the post-operative setting, efforts have been made to address this pain at its root. Prior studies have demonstrated that preoperative administration of acetazolamide decreased post-operative referred pain in the immediate post-surgical period.
PlaceboOther
Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Active comparator | Group 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his pain.
The primary outcome to be assessed is the absolute change in VAS score both in general and at the shoulder tip. This will be measured as the difference between the VAS score obtained pre-operatively, when first responsive after surgery in the post anesthesia care unit (PACU), immediately prior to leaving PACU, and throughout the hospital stay per standard of care.
Δ VAS = Postoperative VAS - Preoperative VAS VAS is a testing technique for measuring subjective or behavioral phenomena (as pain or dietary consumption) in which a subject selects from a gradient of alternatives (as from "no pain" to "worst imaginable pain" or from "every day" to "never") arranged in linear fashion -abbreviation VAS
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start22 Aug 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Johnson, Medical College of Wisconsin
- Investigators
- Scott Johnson, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470843
- Sponsor's protocol ID
- PRO00031299
- Status last verified
- Sep 2022
- First submitted
- 27 Aug 2018
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acetazolamide in Reducing Referred Postoperative Pain After Robotic Assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT04470843
- Acronym / sponsor ID
- PRO00031299
- Conditions
- Prostate Cancer, Men
- Keywords
- Prostatectomy, Acetazolamide, Postoperative Pain, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves removing a man's prostate using a minimally invasive robotic approach under the guidance of a surgeon. In order to gain sufficient access, carbon dioxide (CO2) is used to fill the surgical space in a process termed insufflation. Carbon dioxide is a mainstay in laparoscopic procedures because it is cost-effective, noncombustible and readily excreted via the respiratory system in healthy patients.
Insufflation with CO2, however, has been linked to post-operative referred pain secondary to peritoneal acidosis.This acidosis is suspected to be due to the formation of carbonic acid from the CO2 insufflation.Peritoneal acidosis, and its associated post-operative referred pain, may not be adequately treated with the current standard pain control regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Active comparator | Drug: AcetazolamideGroup 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide |
| Placebo | Placebo comparator | Other: PlaceboGroup 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients ≥18 years of age undergoing robotic-assisted prostatectomy
Key exclusion criteria (12 listed)
- Patients with renal insufficiency with serum creatinine >2.0 mg/dl
- Patients with renal transplant
- Patients with pre-existing metabolic acidosis
- Patients with chronic obstructive pulmonary disease
- Patients with hepatic disease
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 |
|---|---|---|
| AcetazolamideBeing that adequate pain control is essential to recovery in the post-operative setting, efforts have been made to address this pain at its root. Prior studies have demonstrated that preoperative administration of acetazolamide decreased post-operative referred pain in the immediate post-surgical period. | Drug | Acetazolamide |
| PlaceboGroup 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo. | Other | Placebo |
Primary outcome
Visual Analogue Scale (VAS) 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his pain.
Time frame: 24 hours
The primary outcome to be assessed is the absolute change in VAS score both in general and at the shoulder tip. This will be measured as the difference between the VAS score obtained pre-operatively, when first responsive after surgery in the post anesthesia care unit (PACU), immediately prior to leaving PACU, and throughout the hospital stay per standard of care. Δ VAS = Postoperative VAS - Preoperative VAS VAS is a testing technique for measuring subjective or behavioral phenomena (as pain or dietary consumption) in which a subject selects from a gradient of alternatives (as from "no pain" to "worst imaginable pain" or from "every day" to "never") arranged in linear fashion -abbreviation VAS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- 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.
Scott Johnson, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetazolamide in people with Prostate Cancer and Men, run by Medical College of Wisconsin 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 12 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 23 Sep 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Analogue Scale (VAS) 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his pain. (time frame: 24 hours). 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 23 Sep 2022.