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

May 13, 2015 updated by: The University of The West Indies

Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Reducible inguinal hernia

Exclusion Criteria:

  • Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease
  • Body mass index < 18.5 kg/m2 or > 30 kg/m2
  • Recurrent inguinal hernias
  • Bilateral inguinal hernias
  • Large inguinoscrotal hernias
  • Incarcerated hernia
  • Allergies to local anaesthetic and sedative agents
  • Pregnancy
  • Lactation
  • Chronic pain syndromes
  • Anxiety disorders
  • Marijuana use
  • Long term use of opioid or sedative agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Intravenous Normal Saline
Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i
Drug: Intravenous Normal Saline
Intravenous normal saline will be infused by non-blinded anaesthetist
Other Names:
  • 0.9% sodium chloride solution
Drug: Bupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Other Names:
  • Marcaine
Drug: Lignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
Other Names:
  • xylocaine
Active Comparator: Midazolam
Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.
Drug: Bupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Other Names:
  • Marcaine
Drug: Lignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
Other Names:
  • xylocaine
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.
Other Names:
  • Dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
Time Frame: 1 year
Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 2 weeks
2 weeks
Frequency (total count) of postoperative complications using a questionaire
Time Frame: 1 year
1 year
Post-operative assessment of physical activity using Activities Assessment Scale
Time Frame: 1 year
1 year
Time to discharge
Time Frame: 2 weeks
2 weeks
change in postoperative pain score from baseline assessed with visual analog scale
Time Frame: 1 year
change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP342,12/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inguinal Hernia

Clinical Trials on Intravenous Normal Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe