Impact of Acetazolamide in Reducing Referred Postoperative Pain

Medical College of Wisconsin

Status and phase: Completed; Phase 1

Conditions: Men; Prostate Cancer

Treatments: Drug: Acetazolamide; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04470843

PRO00031299

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups, including a placebo group

Acetazolamide

Active Comparator group

Description:

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

Treatment:

Drug: Acetazolamide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo