Back to resultsIntrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
spinal anesthesia with bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) score I-II. Body mass index < 35 kg/m2 Exclusion Criteria: Patient's refusal. Known coagulopathy. Known peripheral neuropathy or neurological deficits. Known allergy to study drugs.
Sites / Locations
- Ain-Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
The duration of motor block (minutes)
The duration of motor block (minutes)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05609565
Brief Title
Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy
Official Title
Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
- Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
Intervention Description
spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
Intervention Type
Drug
Intervention Name(s)
spinal anesthesia with bupivacaine
Intervention Description
spinal anesthesia with bupivacaine
Primary Outcome Measure Information:
Title
The duration of motor block (minutes)
Description
The duration of motor block (minutes)
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) score I-II.
Body mass index < 35 kg/m2
Exclusion Criteria:
Patient's refusal.
Known coagulopathy.
Known peripheral neuropathy or neurological deficits.
Known allergy to study drugs.
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy
We'll reach out to this number within 24 hrs