Inguinal Hernia, Anesthesia, Local, Conscious Sedation
Conditions
Keywords
Inguinal Hernia,, Local Anesthesia, Randomized Clinical trial, HERNIOPLASTY
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
Interventions
DRUGMidazolam
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 saline will be infused by non-blinded anaesthetist
DRUGBupivocaine
Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
DRUGLignocaine HCl
Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
Sponsors
The University of The West Indies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale | 1 year | Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | — |
| Time to discharge | 2 weeks | — |
| change in postoperative pain score from baseline assessed with visual analog scale | 1 year | change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale |
Countries
Jamaica
Contacts
Primary ContactPierre Leake, DM
Backup ContactMarvin Reid, PhD
Outcome results
None listed