Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial.
| Title: | Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial. |
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| Authors: | Leake PA; Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.; Toppin PJ; Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.; Reid M; Tropical Medical Research Institute, University of the West Indies, Kingston, Jamaica.; Plummer JM; Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.; Roberts PO; Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.; Harding-Goldson H; Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica.; McFarlane ME; Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Kingston, Jamaica. |
| Source: | JMIR research protocols [JMIR Res Protoc] 2017 Feb 07; Vol. 6 (2), pp. e20. Date of Electronic Publication: 2017 Feb 07. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Print ISSN: 1929-0748 (Print) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: PubMed not MEDLINE |
| Imprint Name(s): | Original Publication: Toronto : JMIR Publications |
| 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://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).; (©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.) |
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| Contributed Indexing: | Keywords: conscious sedation; inguinal hernioplasty; local anesthesia; patient satisfaction; randomized controlled trial |
| Molecular Sequence: | ClinicalTrials.gov NCT02444260 |
| Entry Date(s): | Date Created: 20170209 Latest Revision: 20201001 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC5320391 |
| DOI: | 10.2196/resprot.6754 |
| PMID: | 28174148 |
| Database: | MEDLINE |
Journal Article