Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.
BACKGROUND
Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard.


OBJECTIVE
To determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty.


METHODS
This trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status.


RESULTS
To date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017.


CONCLUSIONS
This randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines.


BACKGROUND
Clinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Pierre-Anthony
http://orcid.org/0000-0002-7915-7427
PA
Leake
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Patrick J
http://orcid.org/0000-0002-6395-5715
PJ
Toppin
Tropical Medical Research Institute, University of the West Indies, Kingston, Jamaica.
Marvin
http://orcid.org/0000-0003-4005-9384
M
Reid
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Joseph M
http://orcid.org/0000-0001-7371-810X
JM
Plummer
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Patrick O
http://orcid.org/0000-0001-8229-1195
PO
Roberts
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Hyacinth
http://orcid.org/0000-0002-8161-2193
H
Harding-Goldson
Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.
Michael E
http://orcid.org/0000-0003-0813-9974
ME
McFarlane
conscious sedation; inguinal hernioplasty; local anesthesia; patient satisfaction; randomized controlled trial