NCT04470843

Impact of Acetazolamide in Reducing Referred Postoperative Pain

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Men

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-22
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-07-14
• Last updated: 2022-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study