A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation

Specific study objectives are to determine the effect of conscious sedation on:

(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of The West Indies
• Treatments: Anesthetics; Lidocaine; Midazolam; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Reducible inguinal hernia

Exclusion Criteria:

• Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease

• Body mass index < 18.5 kg/m2 or > 30 kg/m2

• Recurrent inguinal hernias

• Bilateral inguinal hernias

• Large inguinoscrotal hernias

• Incarcerated hernia

• Allergies to local anaesthetic and sedative agents

• Pregnancy

• Lactation

• Chronic pain syndromes

• Anxiety disorders

• Marijuana use

• Long term use of opioid or sedative agents