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

Study Overview
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Brief Summary
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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

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

Conditions
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Inguinal Hernia, Anesthesia, Local, Conscious Sedation

Intervention / Treatment
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* Drug: Midazolam
* Drug: Intravenous Normal Saline
* Drug: Bupivocaine
* Drug: Lignocaine HCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Intravenous Normal Saline<br>Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i | Drug: Intravenous Normal Saline<br>* Intravenous normal saline will be infused by non-blinded anaesthetist<br>* Other names: 0.9% sodium chloride solution;Drug: Bupivocaine<br>* Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg<br>* Other names: Marcaine;Drug: Lignocaine HCl<br>* Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg<br>* Other names: xylocaine;|
| Active Comparator: Midazolam<br>Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. | Drug: Midazolam<br>* 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.<br>* Other names: Dormicum;Drug: Bupivocaine<br>* Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg<br>* Other names: Marcaine;Drug: Lignocaine HCl<br>* Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg<br>* Other names: xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | 2 weeks | 
| Frequency (total count) of postoperative complications using a questionaire |  | 1 year | 
| Post-operative assessment of physical activity using Activities Assessment Scale |  | 1 year | 
| Time to discharge |  | 2 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal Hernia,, Local Anesthesia, Randomized Clinical trial, HERNIOPLASTY