Effect of an Anti-spasmodic Suppository to Improve Comfort After Urologic Surgery

NCT02291042 | Completed DMC

• 1 other identifier: 2014-05
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the ability of a belladonna and opium suppository given prior to surgery to improve bladder comfort after surgery for patients who are having elective ureteroscopy surgery.

Conditions

Surgery

Keywords

Bladder; Surgery

Outcome Measures

Primary Outcomes (1)

• Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups

  Bladder comfort is defined as bladder pain and bladder urgency. Bladder pain is measured on a 0-10 verbal analog scale with 0 = no pain and 10 = most pain possible. Bladder urgency is measured by a 0 - 4 scale with 0 = no desire to void, 1 = awarenes of need to void which can be delayed at least 30 minutes, 2 = moderate urgency than can be delayed for no more than 15 minutes, 3 = severe urgency that can be delayed for no more than 5 minutes, 4 = must void now. Pain and urgency are reported by the patient with or without questioning by the nurse.

  Length of postoperative stay from admission to PACU to discharge from PACU an expected average of 2 hours

Secondary Outcomes (1)

• Duration of PACU length of stay

  Time from admission to PACU to discharge from PACU an expected average of 2 hours

Other Outcomes (1)

• Requirements for rescue therapy for pain and urgency

  From PACU admission to PACU discharge an expected average of 2 hours

Study Arms (2)

Suppository

EXPERIMENTAL

Patients will receive a single antispasmodic muscarinic suppository after induction of anesthesia but before insertion of urological scope for surgery. The suppository is composed of Belladonna (16.2 mg) and Opium (30 mg) in a water soluble base manufactured as Belladonna and Opium Supprettes.

Drug: B+O Suppository

Control

NO INTERVENTION

Patients will be provided with routine care.

Interventions

B+O Suppository DRUG

Also known as: Belladona and opium; B+O Supprettes

Suppository

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from one urology practice schedule for elective uteroscopy.

You may not qualify if:

• Patients with pre-operative indwelling catheter or urinary stent.
• Patients who report any allergy to belladonna or opium.

Sponsors & Collaborators

• Southern New Hampshire Medical Center: lead

Related Publications (2)

• Lukasewycz S, Holman M, Kozlowski P, Porter CR, Odom E, Bernards C, Neil N, Corman JM. Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study. Can J Urol. 2010 Oct;17(5):5377-82.

  PMID: 20974030 BACKGROUND

• Scavonetto F, Lamborn DR, McCaffrey JM, Schroeder DR, Gettman MT, Sprung J, Weingarten TN. Prophylactic belladonna suppositories on anesthetic recovery after robotic assisted laparoscopic prostatectomy. Can J Urol. 2013 Jun;20(3):6799-804.

  PMID: 23783051 BACKGROUND

MeSH Terms

Interventions

Opium

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Susan J Fetzer, PHD RN

  Southern New Hampshire Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 29, 2017

Record last verified: 2017-03