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

Primary Purpose

Inguinal Hernia, Anesthesia, Local, Conscious Sedation

Status

Unknown status

Phase

Phase 3

Locations

Jamaica

Study Type

Interventional

Intervention

Midazolam

Intravenous Normal Saline

Bupivocaine

Lignocaine HCl

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal Hernia,, Local Anesthesia, Randomized Clinical trial, HERNIOPLASTY

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of the West Indies, monaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Intravenous Normal Saline

Midazolam

Arm Description

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

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.

Outcomes

Primary Outcome Measures

patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale

Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)

Secondary Outcome Measures

Operative time

Frequency (total count) of postoperative complications using a questionaire

Post-operative assessment of physical activity using Activities Assessment Scale

Time to discharge

change in postoperative pain score from baseline assessed with visual analog scale

change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale

Full Information

NCT ID

NCT02444260

First Posted

April 28, 2015

Last Updated

May 13, 2015

Sponsor

The University of The West Indies

1. Study Identification

Unique Protocol Identification Number

NCT02444260

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of The West Indies

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia, Anesthesia, Local, Conscious Sedation

Keywords

Inguinal Hernia,, Local Anesthesia, Randomized Clinical trial, HERNIOPLASTY

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous Normal Saline

Arm Type

Sham Comparator

Arm Description

Arm Title

Midazolam

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Midazolam

Other Intervention Name(s)

Dormicum

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Intravenous Normal Saline

Other Intervention Name(s)

0.9% sodium chloride solution

Intervention Description

Intravenous normal saline will be infused by non-blinded anaesthetist

Intervention Type

Drug

Intervention Name(s)

Bupivocaine

Other Intervention Name(s)

Marcaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lignocaine HCl

Other Intervention Name(s)

xylocaine

Intervention Description

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

Primary Outcome Measure Information:

Title

patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale

Description

Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Operative time

Time Frame

2 weeks

Title

Frequency (total count) of postoperative complications using a questionaire

Time Frame

1 year

Title

Post-operative assessment of physical activity using Activities Assessment Scale

Time Frame

1 year

Title

Time to discharge

Time Frame

2 weeks

Title

change in postoperative pain score from baseline assessed with visual analog scale

Description

change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Leake, DM

Pierre-Anthony Leake <paeleake@yahoo.com>

First Name & Middle Initial & Last Name or Official Title & Degree

Marvin Reid, PhD

marvin.reid@uwimona.edu.jm

Facility Information:

Facility Name

University of the West Indies, mona

City

Kingston

State/Province

Please Select

Country

Jamaica

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre Leake, DM

Pierre-Anthony Leake <paeleake@yahoo.com>

12. IPD Sharing Statement

Citations:

PubMed Identifier

28174148

Citation

Leake PA, Toppin PJ, Reid M, Plummer JM, Roberts PO, Harding-Goldson H, McFarlane ME. Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Feb 7;6(2):e20. doi: 10.2196/resprot.6754.

Results Reference

derived

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

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