NCT02444260

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

Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: The University of The West Indies · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Inguinal Hernia
• Anesthesia, Local
• Conscious Sedation

Interventions

Type	Name	Description
DRUG	Midazolam	Midazolam will administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. Additional sedation will be given to achieve and maintain a score of 2-3 on the Ramsay sedation scale during the procedure, up to the maximum dose of 10mg.
DRUG	Intravenous Normal Saline	Intravenous normal saline will be infused by non-blinded anaesthetist
DRUG	Bupivocaine	Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
DRUG	Lignocaine HCl	Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2015-05-14
• Last updated: 2015-05-14

Locations

1 site across 1 country: Jamaica