Impact of Acetazolamide in Reducing Referred Postoperative Pain

Straipsnius versti gali tik registruoti vartotojai

Prisijungti Registracija

Nuoroda įrašoma į mainų sritį

StatusasVerbavimas

Rėmėjai

Medical College of Wisconsin

KLINIKINIS TYRIMAS: NCT04470843

BioSeek: nct04470843

Raktažodžiai

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	06/30/2020
Pirmasis pateikimas:	08/26/2018
Numatytas registravimas pateiktas:	07/12/2020
Pirmas paskelbtas:	07/13/2020
Paskutinis atnaujinimas pateiktas:	07/12/2020
Paskutinis atnaujinimas paskelbtas:	07/13/2020
Faktinė studijų pradžios data:	08/21/2018
Numatoma pirminio užbaigimo data:	11/30/2020
Numatoma studijų užbaigimo data:	07/31/2021

Būklė ar liga

Prostate Cancer

Men

Intervencija / gydymas

Drug: Acetazolamide

Other: Placebo

Fazė

Fazė 1

Rankų grupės

Ranka	Intervencija / gydymas
Active Comparator: Acetazolamide Group 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide	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.
Placebo Comparator: Placebo Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.	Other: Placebo Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	Male
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

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. [24 hours]

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

Impact of Acetazolamide in Reducing Referred Postoperative Pain

Raktažodžiai

vėžys

kraujavimas

acidozė

carbonic acid