Triple Injection Peri-sartorius (TIPS) Block
Primary Purpose
Knee Disease, Nerve Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided triple injection peri-sartorius block
Femoral Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Knee Disease
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III 80 patients scheduled for unilateral total knee arthroplasty -
Exclusion Criteria:
- BMI > 35 kg/m2, Pre-existing neurological deficit, Any disability of the non-operated limb preventing fair mobilization, Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), Chronic opioid users/abusers
Sites / Locations
- Alexandria Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TIPS Block
FNB
Arm Description
Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision
Group FNB; patients will receive femoral nerve block (FNB) before surgical incision
Outcomes
Primary Outcome Measures
Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)
Compare the two groups regarding the visual analogue scale scores
Secondary Outcome Measures
Total postoperative morphine consumption
Compare the total postoperative opioid (morphine) consumption after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB
Operated limb motor power
Compare the two groups regarding the operated limb motor power
Complications
Compare the two groups regarding complications of the two techniques and opioid related side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289427
Brief Title
Triple Injection Peri-sartorius (TIPS) Block
Official Title
Triple Injection Peri-sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA): Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB)
Detailed Description
Introduction: Adequate pain control, along with quadriceps muscle preservation, has become a goal among orthopedic departments following TKA(1). The femoral nerve block (FNB) has been for many years the gold standard analgesic therapy for TKA however, it leads to quadriceps weakness(2).
Subsartorial block has been originally prescribed to block sensation in the front and the medial aspect of the knee with little quadriceps weakness (3). Local anaesthetic (LA) injected at the distal third of the adductor canal may enter into the popliteal region along with the femoral vessels to involve the popliteal plexus which supplies the posterior knee joint capsule (4). The anterior femoral cutaneous nerve (AFCN) is the overall term for the intermediate femoral cutaneous nerves (IFCNs) and the medial femoral cutaneous nerve (MFCN). The MFCN innervates the distal medial thigh as well as the anteromedial knee region. It may be anesthetized in the proximal part of the femoral triangle. The IFCN innervates the distal anterior thigh, which includes the proximal part of the surgical incision for TKA. They can be ultrasonographically identified and targeted in the subcutaneous plane on the anterior thigh where they pierce the fascia lata (FL) anterior to the sartorius muscle (SAM) before they ramify in multiple branches(5).
We hypothesize that injection of LA at the femoral triangle level above and below the sartorius muscle and at the distal end of the adductor canal may provide superior analgesia to femoral nerve block alone with little quadriceps weakness in TKA.
Aim of the study: The primary aim of this study is to compare the visual analogue scale scores during the 1st 24 postoperative hours after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB.
The secondary aims of this study are to compare the total postoperative opioid (morphine) consumption, evaluate the effect of the two techniques on the motor power of the operated limb and to detect any complications related to the block or opioids used.
Methods: After obtaining approval from Alexandria university ethics committee, this study will be carried out in El-Hadara university hospital on American Society of Anesthesiologists (ASA) physical status I-III 80 patients scheduled for unilateral TKA. A total sample size of 80 patients, 40 in each group will be sufficient to provide more than 80 % power at a two sided 0.05 significance level. The exclusion criteria will include; BMI > 35 kg/m2, pre-existing neurological deficit, any disability of the non-operated limb preventing fair mobilization, known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), or chronic opioid users/abusers.
Patients will be divided into 2 groups. Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision. Group FNB; patients will receive femoral nerve block (FNB) before surgical incision.
Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Plan of anaesthesia will be determined by the anesthesiologist in charge. After induction of general anaesthesia or administration of spinal anaesthesia, patients will be randomly divided by a closed envelope method into two groups:
Group TIPS: Patients will receive a combination of supra-sartorius plane block, femoral triangle block and distal ACB. Ten ml of 0.25 % bupivacaine will be injected. Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. The needle will be withdrawn subcutaneously and another 10 ml of local anesthetic will be injected above the sartorius and below the fascia lata (5). Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially.(6) Group FNB: Patients will receive single injection of 20 ml 0.25 % bupivacaine mixed with 4 mg dexamethasone about 2 cm below the inguinal ligament. LA mixture will be injected under the fascia iliaca just lateral to the femoral nerve. The femoral artery at this level will appear as a single vessel before bifurcation into profunda femoris and superficial femoral artery.
Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine at a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 hour follow up period. Total postoperative morphine requirements will be measured during the postoperative follow up period.
Rehabilitation through physical therapy will be performed by patients during the 24 hour follow up period. Ambulation distances from both morning and evening sessions will be combined into a total ambulatory distance for comparative purposes. Active postoperative knee extension while patients are in seated position will be normalized into degrees of flexion (90°-0°). Physical therapy data will be obtained from physical therapy notes. Postoperative complications related to opioid usage like nausea and vomiting or related to the block like neurological symptoms or falls will be recorded. Postoperative patient satisfaction will be recorded after 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Disease, Nerve Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIPS Block
Arm Type
Experimental
Arm Description
Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision
Arm Title
FNB
Arm Type
Active Comparator
Arm Description
Group FNB; patients will receive femoral nerve block (FNB) before surgical incision
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided triple injection peri-sartorius block
Intervention Description
Patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Patients will receive femoral nerve block (FNB) before surgical incision
Primary Outcome Measure Information:
Title
Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)
Description
Compare the two groups regarding the visual analogue scale scores
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total postoperative morphine consumption
Description
Compare the total postoperative opioid (morphine) consumption after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB
Time Frame
24 hours postoperatively
Title
Operated limb motor power
Description
Compare the two groups regarding the operated limb motor power
Time Frame
24 hours postoperatively
Title
Complications
Description
Compare the two groups regarding complications of the two techniques and opioid related side effects
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III 80 patients scheduled for unilateral total knee arthroplasty -
Exclusion Criteria:
BMI > 35 kg/m2, Pre-existing neurological deficit, Any disability of the non-operated limb preventing fair mobilization, Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), Chronic opioid users/abusers
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21651
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the resultsrepoted in this article after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
After statistical analysis
IPD Sharing Access Criteria
Any
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Triple Injection Peri-sartorius (TIPS) Block
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