Impact of Acetazolamide in Reducing Referred Postoperative Pain

Prostate Cancer Clinical Trial

Official title:

Impact of Acetazolamide in Reducing Referred Postoperative Pain After Robotic Assisted Laparoscopic Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470843
• Other study ID #: PRO00031299
• Status: Completed
• Phase: Phase 1
• Start date: August 22, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Men
• Pain, Postoperative
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Acetazolamide
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.

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

Locations

Country	Name	City	State
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; ? 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	24 hours