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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
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 will be infused by non-blinded anaesthetist
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
University of the West Indies, mona
Kingston, Please Select, Jamaica
RECRUITINGpatient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)
Time frame: 1 year
Operative time
Time frame: 2 weeks
Frequency (total count) of postoperative complications using a questionaire
Time frame: 1 year
Post-operative assessment of physical activity using Activities Assessment Scale
Time frame: 1 year
Time to discharge
Time frame: 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
Time frame: 1 year
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