NCT05220813UnknownPhase 4
Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study
Conditions
Interventions
Drugs
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)
Active Comparator
44 patients will receive local infiltration anesthesia.
Intervention: Lidocaine (Drug)
ilioinguinal iliohypogastric group
Active Comparator
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
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1
Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study)Anesthesia, LocalNCT06362915Ain Shams University52
Unknown
Not Applicable
Pediatric Ilioinguinal / Iliohyogogastric Nerve BlockIntra-operative Anesthesia and Analgesia EffectsNCT02990884Erzincan University60
Completed
Not Applicable
Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)Aortic Valve StenosisNCT03863899Medical University of Gdansk100
Completed
Not Applicable
Ilioinguinal Iliohypogastric Nerve Block as Adjunct to Spinal Anesthesia for Cesarean SectionCesarean SectionPost Operative PainNCT06108895Tanta University90
Not yet recruiting
Not Applicable
The effect of ilio-inguinal block of iliohypogastric on analgesia in childreIntraoperative and postoperative pain.IRCT20201126049500N1Tehran University of Medical Sciences63