Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Ain Shams University
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- conversion to general anesthesia.
Study Overview
Brief Summary
To assess the effect of iliohypogastric and ilioinguinal nerve block on the hemodynamic stability ,narcotic consumption and the rate of conversion to general anesthesia in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Patients undergoing TF-TAVI.
- •Both sexes.
- •Age 18 and above
Exclusion Criteria
- •• Inability to tolerate supine position as in patients with musculoskeletal disease or back pain, OR in patients with congestive heart failure or with obstructive sleep apnea.
- •Patients with severe pulmonary hypertension (PAP>60 mmhg)
- •Barrier to communications as language barrier or dementia.
- •Patients' preference of general anesthesia.
- •Surgical consideration as transapical, subclavian approach, extensive TEE requirements.
- •Patients with history of allergy to any drugs used.
- •Patients with psychiatric disease.
- •Patients with neurocognitive or neurodegenerative disease.
- •Secondary exclusion criteria include abortion of the procedure, perioperative emergency conversion to general anesthesia and the need to cardiopulmonary resuscitation so the primary endpoint couldn't be detected in these conditions.
Arms & Interventions
local anesthetic group (control group)
44 patients will receive local infiltration anesthesia.
Intervention: Lidocaine (Drug)
ilioinguinal iliohypogastric group
44patients will receive ilioinguinal iliohypogastric nerve blocks
Intervention: Bupivacain (Drug)
Outcomes
Primary Outcomes
conversion to general anesthesia.
Time Frame: during the procedure (intraoperatively)
Conversion to general anesthesia in other than procedure related causes.
Secondary Outcomes
- fentanyl dose(during the procedure (intraoperatively))
- propofol dose(during the procedure (intraoperatively))
- sedation score(during the procedure (intraoperatively))
Investigators
Ismail Mohammed
principal investigator
Ain Shams University
