A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
Phase 3
- Conditions
- Inguinal HerniaAnesthesia, LocalConscious Sedation
- Interventions
- Registration Number
- NCT02444260
- Lead Sponsor
- The University of The West Indies
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous Normal Saline Intravenous Normal Saline 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 Intravenous Normal Saline Bupivocaine 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 Midazolam Bupivocaine 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. Intravenous Normal Saline Lignocaine HCl 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 Midazolam Midazolam 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. Midazolam Lignocaine HCl 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.
- Primary Outcome Measures
Name Time Method patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale 1 year Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)
- Secondary Outcome Measures
Name Time Method 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 1 year change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale
Operative time 2 weeks Frequency (total count) of postoperative complications using a questionaire 1 year
Trial Locations
- Locations (1)
University of the West Indies, mona
🇯🇲Kingston, Please Select, Jamaica