search
Back to results

Impact of Acetazolamide in Reducing Referred Postoperative Pain

Primary Purpose

Prostate Cancer, Men

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatectomy, Acetazolamide, Postoperative Pain, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

• Male patients ≥18 years of age undergoing robotic-assisted prostatectomy

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Froedtert Memorial Lutheran Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm Description

Group 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide

Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2018
Last Updated
September 22, 2022
Sponsor
Medical College of Wisconsin
search

1. Study Identification

Unique Protocol Identification Number
NCT04470843
Brief Title
Impact of Acetazolamide in Reducing Referred Postoperative Pain
Official Title
Impact of Acetazolamide in Reducing Referred Postoperative Pain After Robotic Assisted Laparoscopic Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Men
Keywords
Prostatectomy, Acetazolamide, Postoperative Pain, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
Group 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
24 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males having a robotic-assisted prostatectomy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Male patients ≥18 years of age undergoing robotic-assisted prostatectomy Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Johnson, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Acetazolamide in Reducing Referred Postoperative Pain

We'll reach out to this number within 24 hrs