Impact of Acetazolamide in Reducing Referred Postoperative Pain

NCT ID: NCT04470843

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2021-03-31

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.

Conditions

Prostate Cancer; Men

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acetazolamide

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

Group Type: ACTIVE_COMPARATOR

Acetazolamide

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Scott Johnson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00031299

Identifier Type: -

Identifier Source: org_study_id