- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382297
Effect of Adding Ultrasound Guided IPACK Block to Adductor Canal Block for Postoperative Pain in Knee Tumor Excision
Analgesic Efficacy of Adding Ultra Sound Guided IPACK Block to Adductor Canal Block for Postoperative Pain Management After Excision of Tumors Around Knee: a Randomized Controlled Trial
the aim of this study is to determine the analgesic effect of iPACK in combination to ACB after the excision of tumors around the Knee regarding the following:
- Time to the 1st rescue analgesia.
- Postoperative morphine consumption.
- Postoperative visual analogue scale (VAS). This study will include patients, aged 18 to 65 years, belonging to the American Society of Anesthesiologists (ASA) physical status II to IV , undergoing excision of tumors around the knee under spinal anesthesia.
Patients will be randomly allocated Group iPACK plus Adductor canal block (ACB) : patients will receive ACB plus iPACK block.
• Control group : patients will not receive any block but will take morphine 3mg bolus at VAS more than 4 and regular NSAIDS and paracetamol iv.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Immediate alleviation of postoperative pain after knee surgeries is critical for patients' postoperative recovery. Ineffective pain management may result in an extended hospital stay and rehabilitation period, as well as the development of chronic pain Non-opioid analgesics are insufficient to alleviate the pain that is intended to be relieved.
Although using Opioids have concerns regarding their potential side effects, which encompass nausea, vomiting, respiratory depression, and addiction Multimodal analgesia, which may include preemptive analgesia, neuraxial blockade, peripheral nerve block, and narcotic and non-narcotic analgesics, is an optimal approach for the management of acute pain following knee surgeries Adductor canal block (ACB) is an interfascial plane infiltration of local anesthetic used to block a portion of the saphenous nerve, which originates in the adductor canal, as well as the obturator nerve ACB combined with an iPACK block results in significantly better postoperative visual analog scale (VAS) scores, knee ranges of motion, as well as ambulation distances compared with ACB alone
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Norma Osama Abdallah Zayed, MD
- Phone Number: 01067843111
- Email: norma.osama@nci.cu.edu.eg
Study Contact Backup
- Name: Fady Attef, MSc
- Phone Number: 01224046183
Study Locations
-
-
-
Cairo, Egypt, 11769
- Recruiting
- National Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- American Society of Anesthesiologists (ASA) physical status II-IV.
- Patients undergoing excision of tumors around the knee under spinal anesthesia
Exclusion Criteria:
- Patient refusal.
- Neuromuscular disorders
- Allergy to local anesthetics
- Previous history of knee surgery
- Patients with a prior knee infection
- Contraindications to spinal anesthesia as coagulopathies and severe aortic stenosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: adductor canal block with iPACK
The adductor canal will be identified.
a spinal needle 22 gauge x 3.5 inches will be advanced with the guidance of ultrasound in an in-plane technique, and 15ml of 0.5% bupivacaine will be injected then IPACK block will be performed The probe will be applied to the popliteal fossa for identification of the popliteal artery and femur.
Then, the probe will be slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared.
a spinal needle 22G x 3.5 inches will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration will be confirmed and 15ml of 0.5% bupivacaine will be injected incrementally as the needle will be withdrawn.
|
The adductor canal will be identified.
a spinal needle 22 gauge x 3.5 inches will be advanced with the guidance of ultrasound in an in-plane technique ,and 15ml of 0.5% bupivacaine will be injected then IPACK block will be performed.
The probe will be applied to the popliteal fossa for identification of the popliteal artery and femur.
Then, the probe will be slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared.
a spinal needle 22G x 3.5 inches will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration will be confirmed and 15ml of 0.5% bupivacaine will be injected incrementally as the needle will be withdrawn
|
|
Other: control group
visualizing the adductor canal without doing any block for the control group
|
The probe will be positioned at the midpoint between the anterior superior iliac spine and the upper pole of the patella. The adductor canal, which is a hyperechoic structure situated beneath the sartorius muscle, will be identified but no block will be done |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the 1st rescue analgesia
Time Frame: 24 hours postoperative
|
Time to the 1st rescue analgesia
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: first 24 hour
|
morphine consumed in 1st 24 hours postoperative in mg
|
first 24 hour
|
|
pain score ( visual analogue scale)
Time Frame: at 2 hours ,4 hours,6 hours, 12 hours,18 hours and 24 h postoperatively
|
assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain |
at 2 hours ,4 hours,6 hours, 12 hours,18 hours and 24 h postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ghada Gamal Eldin Elsayed, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP2407-201-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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