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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02444260
Other study ID # ECP342,12/13
Secondary ID
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
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


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
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