Inguinal HerniaPhase 3NCT02444260
A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
A Phase 3 study testing Midazolam, Intravenous Normal Saline and Bupivocaine in people with Inguinal Hernia and Anesthesia, Local, run by The University of The West Indies at 1 site in Jamaica.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Hernia, Anesthesia, Local, Conscious Sedation
- What is being tested?
- Midazolam, Intravenous Normal Saline and Bupivocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteJamaica
- Study dates
- Dec 2013to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reducible inguinal hernia
Who cannot join
- 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
Show all 13Show fewer
- Allergies to local anaesthetic and sedative agents
- Pregnancy
- Lactation
- Chronic pain syndromes
- Anxiety disorders
- Marijuana use
- Long term use of opioid or sedative agents
Trial locations and contacts
1 site in 1 country.
Pierre Leake, DM contact
Marvin Reid, PhD contact
Jamaica1 site, 1 recruiting
- Recruiting
University of the West Indies, mona
Kingston, Please Select
Pierre Leake, DM, Pierre-Anthony Leake <paeleake@yahoo.com>
About this study
Official title: 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
- Conditions
- Inguinal Hernia, Anesthesia, Local, Conscious Sedation
- Being tested
- Midazolam, Intravenous Normal Saline, Bupivocaine, Lignocaine HCl
- Keywords
- Inguinal Hernia,, Local Anesthesia, Randomized Clinical trial, HERNIOPLASTY
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Dormicum
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.
Intravenous Normal SalineDrug
Also called 0.9% sodium chloride solution
Intravenous normal saline will be infused by non-blinded anaesthetist
BupivocaineDrug
Also called Marcaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Lignocaine HClDrug
Also called xylocaine
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Normal Saline | Sham comparator | 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 Receives: Drug: Intravenous Normal Saline; Drug: Bupivocaine; Drug: Lignocaine HCl |
| Midazolam | Active comparator | 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. Receives: Drug: Midazolam; Drug: Bupivocaine; Drug: Lignocaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)
Measured: 1 year
Secondary outcomes (5)
Operative time
Measured: 2 weeks
Frequency (total count) of postoperative complications using a questionaire
Measured: 1 year
Post-operative assessment of physical activity using Activities Assessment Scale
Measured: 1 year
Time to discharge
Measured: 2 weeks
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444260
- Sponsor's protocol ID
- ECP342,12/13
- Status last verified
- Mar 2015
- First submitted
- 28 Apr 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28174148
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation
- ClinicalTrials.gov ID
- NCT02444260
- Acronym / sponsor ID
- ECP342,12/13
- Conditions
- Inguinal Hernia, Anesthesia, Local, Conscious Sedation
- Keywords
- Inguinal Hernia,, Local Anesthesia, Randomized Clinical trial, HERNIOPLASTY
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Normal Saline | Sham comparator | Drug: Intravenous Normal Saline, Drug: Bupivocaine, Drug: Lignocaine HClIntravenous 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 |
| Midazolam | Active comparator | Drug: Midazolam, Drug: Bupivocaine, Drug: Lignocaine HClLignocaine 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Reducible inguinal hernia
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: DormicumMidazolam 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 | Midazolam |
| Intravenous Normal SalineAlso: 0.9% sodium chloride solutionIntravenous normal saline will be infused by non-blinded anaesthetist | Drug | Intravenous Normal Saline |
| BupivocaineAlso: MarcaineBupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg | Drug | Intravenous Normal Saline, Midazolam |
| Lignocaine HClAlso: xylocaineLignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg | Drug | Intravenous Normal Saline, Midazolam |
Primary outcome
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)
5 secondary outcomes
Operative time
Time frame: 2 weeks
Frequency (total count) of postoperative complications using a questionaire
Time frame: 1 year
Post-operative assessment of physical activity using Activities Assessment Scale
Time frame: 1 year
Time to discharge
Time frame: 2 weeks
change in postoperative pain score from baseline assessed with visual analog scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Derived from this study: PubMed 28174148Leake 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Leake, DM contact
Marvin Reid, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midazolam, Intravenous Normal Saline and Bupivocaine in people with Inguinal Hernia and Anesthesia, Local, run by The University of The West Indies at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Leake, DM (Pierre-Anthony Leake <paeleake@yahoo.com>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.