Impact of Acetazolamide in Reducing Referred Postoperative Pain

NCT04470843 | Completed Phase 1 FDA Drug

• 1 other identifier: PRO00031299
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Prostatectomy; Acetazolamide; Postoperative Pain; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Study Arms (2)

Acetazolamide

ACTIVE COMPARATOR

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

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Acetazolamide 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.

Acetazolamide

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males having a robotic-assisted prostatectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Multiple Endocrine Neoplasia Type 1; Pain, Postoperative

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Scott Johnson, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: July 14, 2020
• Study Start: August 22, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)