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A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty

NCT02444260 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-05-14

No results posted yet for this study

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

Conditions

  • Inguinal Hernia
  • Anesthesia, Local
  • Conscious Sedation

Interventions

DRUG

Midazolam

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.

DRUG

Intravenous Normal Saline

Intravenous normal saline will be infused by non-blinded anaesthetist

DRUG

Bupivocaine

Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg

DRUG

Lignocaine HCl

Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg

Sponsors & Collaborators

  • The University of The West Indies

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Jamaica

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444260 on ClinicalTrials.gov