Back to resultsValue of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain focused on measuring IPACK Block, spinal anesthesia, Knee arthroscopy.
Eligibility Criteria
Inclusion Criteria: age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy Exclusion Criteria: Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis
Sites / Locations
- Mohamed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group F
group I
Arm Description
received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).
Outcomes
Primary Outcome Measures
post-operative analgesia
post-operative pain relief
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05833776
Brief Title
Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy
Official Title
Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia on Postoperative Analgesia for Knee Arthroscopic Meniscectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. However, despite its benefits, this method has been associated to an increased incidence of urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has been employed in practice.
Detailed Description
The goal of this study was to compare fentanyl based spinal anesthesia to IPACK Block-based spinal anesthesia during knee arthroscopy.
Patients and Methods: The study enrolled sixty patients with ASA (I-II) ranging in age from 25 to 60 years old after receiving ethical committee permission and written informed consent from patients. They were divided into two groups: group F (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) and group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). Results: In the first 4 hours postoperatively, there were no variations in VAS scores between the two groups; however, following 4 hours and over the next 12 hours, Group I, VAS scores were lower. The amount of morphine used overall was lower in Group I, which took longer than Group F to reach initial rescue analgesia. The level of patient satisfaction 48 hours after surgery was higher in group I than in group F.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
IPACK Block, spinal anesthesia, Knee arthroscopy.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group F
Arm Type
Experimental
Arm Description
received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
Arm Title
group I
Arm Type
Experimental
Arm Description
group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).
Intervention Type
Procedure
Intervention Name(s)
spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
Intervention Description
group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).
Primary Outcome Measure Information:
Title
post-operative analgesia
Description
post-operative pain relief
Time Frame
24 hours
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy
Exclusion Criteria:
Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis
Facility Information:
Facility Name
Mohamed
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy
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