Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial

Pierre-Anthony Leake, Patrick J Toppin, Marvin Reid, Joseph M Plummer, Patrick O Roberts, Hyacinth Harding-Goldson, Michael E McFarlane, Pierre-Anthony Leake, Patrick J Toppin, Marvin Reid, Joseph M Plummer, Patrick O Roberts, Hyacinth Harding-Goldson, Michael E McFarlane

Abstract

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.

Trial registration: Clinicaltrials.gov NCT02444260; https://ichgcp.net/clinical-trials-registry/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).

Keywords: conscious sedation; inguinal hernioplasty; local anesthesia; patient satisfaction; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

©Pierre-Anthony Leake, Patrick J Toppin, Marvin Reid, Joseph M Plummer, Patrick O Roberts, Hyacinth Harding-Goldson, Michael E McFarlane. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.02.2017.

Figures

Figure 1
Figure 1
Flowchart summarizing study procedures and participant flow through each stage. BMI: body mass index; LA: local anesthesia.

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