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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale | Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | 2 weeks | |
| Frequency (total count) of postoperative complications using a questionaire | 1 year | |
| Post-operative assessment of physical activity using Activities Assessment Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Leake, DM | Contact | Pierre-Anthony Leake <paeleake@yahoo.com> | ||
| Marvin Reid, PhD | Contact | marvin.reid@uwimona.edu.jm |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the West Indies, mona | Recruiting | Kingston | Please Select | Jamaica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28174148 | Derived | 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. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Intravenous Normal Saline | Drug | Intravenous normal saline will be infused by non-blinded anaesthetist |
|
|
| Bupivocaine | Drug | Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg |
|
|
| Lignocaine HCl | Drug | Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg |
|
|
| 1 year |
| Time to discharge | 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 | 1 year |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |