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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444260
• Other study ID #: ECP342,12/13
• Status: Recruiting
• Phase: Phase 3
• First received: April 28, 2015
• Last updated: May 13, 2015
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: The University of The West Indies
• Contact: Pierre Leake, DM
• Email: Pierre-Anthony Leake [@]yahoo.com>
• Is FDA regulated: No
• Health authority: Jamaica: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Local
• Conscious Sedation
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.
• Intravenous Normal Saline
Intravenous normal saline will be infused by non-blinded anaesthetist
• Bupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
• Lignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg

Locations

Country	Name	City	State
Jamaica	University of the West Indies, mona	Kingston	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale	Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)	1 year	No
Secondary	Operative time		2 weeks	No
Secondary	Frequency (total count) of postoperative complications using a questionaire		1 year	No
Secondary	Post-operative assessment of physical activity using Activities Assessment Scale		1 year	No
Secondary	Time to discharge		2 weeks	Yes
Secondary	change in postoperative pain score from baseline assessed with visual analog scale	change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale	1 year	No