Anesthesia, Local Clinical Trial
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
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Jamaica | University of the West Indies, mona | Kingston | Please Select |
Lead Sponsor | Collaborator |
---|---|
The University of The West Indies |
Jamaica,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Operative time | 2 weeks | No | |
Secondary | Frequency (total count) of postoperative complications using a questionaire | 1 year | No | |
Secondary | Post-operative assessment of physical activity using Activities Assessment Scale | 1 year | No | |
Secondary | Time to discharge | 2 weeks | Yes | |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03663478 -
Continuous TQL Block for Elective Cesarean Section
|
Phase 4 | |
Completed |
NCT04513652 -
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
|
Phase 3 | |
Completed |
NCT05464862 -
The Effect of PPB Using 10, 20 and 30 ml of Lidocaine, Study on Volunteers
|
Phase 4 | |
Completed |
NCT04690647 -
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
|
N/A | |
Completed |
NCT03245359 -
Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks
|
N/A | |
Recruiting |
NCT06028126 -
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
|
N/A | |
Not yet recruiting |
NCT05815563 -
Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
|
||
Completed |
NCT01418690 -
Changes in Tissue Oxygenation Following Regional Anesthesia
|
N/A | |
Suspended |
NCT03291691 -
Protective Nerve Stimulation in Regional Anesthesia
|
||
Not yet recruiting |
NCT03545516 -
Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery
|
Phase 2 | |
Not yet recruiting |
NCT05038007 -
Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades
|
Phase 2 | |
Terminated |
NCT03672500 -
Perineal Local Infiltration Study
|
N/A | |
Enrolling by invitation |
NCT06057090 -
Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
|
N/A | |
Recruiting |
NCT05415865 -
The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
|
Phase 3 | |
Recruiting |
NCT06011005 -
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.
|
N/A | |
Completed |
NCT04536311 -
Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block
|
N/A | |
Completed |
NCT03600454 -
The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response
|
N/A | |
Recruiting |
NCT03159338 -
Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy
|
N/A | |
Completed |
NCT02966067 -
A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery
|
N/A | |
Completed |
NCT03305666 -
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
|
Phase 4 |