Postoperative Urinary Retention in Orthopedic Patients

NCT04298775 | Completed

• 1 other identifier: 20160443
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to compare the incidence of postoperative urinary retention related to spinal anesthesia with morphine and spinal anesthesia associated with peripheral blockade in orthopedic procedures of lower limbs. Secondary objectives are assessing the incidence of nausea and vomiting; postoperative pain and opioid consumption at 24 hours after surgery with each of the techniques. A total of 52 patients submitted to a lower limb orthopedic procedure were randomized to the intervention groups: spinal anesthesia with morphine versus spinal anesthesia without opioid associated with peripheral nerve block. After surgery, bladder ultrasound will be performed in post-anesthesia care unit to identify urinary retention and patients will be followed for 24 hours to assess outcomes.

Conditions

Urinary Retention; Anesthesia, Spinal; Orthopedic Procedures; Nerve Block

Outcome Measures

Primary Outcomes (2)

• Postoperative urinary retention

  Need for bladder catheterization in the first 24 hours after surgical procedure

  In 24 hours after surgical procedure

• Postoperative urinary retention

  Time required for first spontaneous urination in the first 24 hours after surgical procedure

  In 24 hours after surgical procedure

Secondary Outcomes (3)

• Nausea and vomiting

  In 24 hours after surgical procedure

• Postoperative pain: Visual Analog Scale (VAS)

  In 12 and 24 hours after surgical procedure

• Opioid consumption

  In the first 24 hours after surgical procedure

Study Arms (2)

spinal anesthesia with morphine

ACTIVE COMPARATOR

This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine + 200 mcg of Morphine

Procedure: spinal anesthesia with morphine

spinal anesthesia without morphine + peripheral nerve block

ACTIVE COMPARATOR

This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine and peripheral nerve block with 0.2 to 0.375% Ropivacaine, in a volume of 20 to 30 mL.

Procedure: spinal anesthesia without morphine + peripheral nerve block

Interventions

spinal anesthesia with morphine PROCEDURE

spinal anesthesia with morphine

spinal anesthesia without morphine + peripheral nerve block PROCEDURE

spinal anesthesia without morphine + peripheral nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective orthopedic surgeries of the lower limbs
• Possibility and acceptance of performing the surgical procedure under spinal anesthesia
• Minimum hospital stay of 24 hours
• Acceptance and signature of the informed consent form

You may not qualify if:

• Subjects who did not understand the Portuguese language
• Patients who did not agree with the informed consent term and / or did not sign
• Patients with a history of urological problems
• Severe cognitive disorders
• Patients who were unable to urinate spontaneously before surgery

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Urinary Retention

Interventions

Anesthesia, Spinal; Morphine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Carolina L Schiavo, M.D, M.Sc

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 6, 2020
• Study Start: January 1, 2017
• Primary Completion: July 13, 2019
• Study Completion: July 13, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03