Which approach of Ultrasound guided continuous adductor canal block provide better pain relief in patients after Total Knee Replacement Surgery
- Conditions
- Osteoarthritis of knee, unspecified,
- Registration Number
- CTRI/2019/11/021935
- Lead Sponsor
- Lady Hardinge Medical College
- Brief Summary
**INTRODUCTION**
Total knee arthroplasty (TKA) is a common surgery performed for patients with symptomatic osteoarthritis of the knee joint. Since the knee joint is richly supplied by multiple nerves and total knee arthroplasty requires extensive manipulation of the joint and bone resection, the surgery is associated with significant postoperative pain which often delays ambulation. To provide postoperative analgesia in patients undergoing total knee arthroplasty various modalities are used like an epidural catheter, intra-articular infiltration of local anesthetic, intra-articular opioid injections or a site-specific peripheral nerve blocks.
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Peripheral nerve blocks alleviate risks and complications associated with an epidural block like the risk of an accidental intrathecal block, loss of autonomic function like poor bladder control, epidural hematoma formation as well as risks associated with perioperative use of low molecular weight heparin in patients undergoing total knee arthroplasty. Additionally, an ultrasound-guided adductor canal block is primarily a sensory block and thus advocated over femoral nerve block by several studies due to lower incidences of quadriceps weakness and early postoperative ambulation with equivalent postoperative analgesia.
Two approaches for placing the adductor canal catheter have been defined. A standard distal approach at the level where the femoral artery is visualized deep to the sartorius muscle (trans-sartorial) just before it drops into the adductor hiatus. A more proximal approach of
catheter insertion is described at the midpoint of thigh between the inguinal crease and the patella. This proximal approach has been shown to provide a more complete analgesic coverage by recent studies suggesting the additional spread of drug to the popliteal fossa via the adductor hiatus, accessory adductor hiatus and via fascial planes thereby involving the sciatic nerve distribution to the knee.
**LACUNAE IN EXISTING KNOWLEDGE**
Multiple reports have shown a spread of injected drug to the popliteal fossa with a more proximal approach of adductor canal block. However, comparative studies on the analgesic efficacy in terms of intensity and site of pain relief between the proximal versus distal approaches of Ultrasound-guided continuous adductor canal block are lacking.
**RESEARCH QUESTION**
Which approach between proximal versus distal ultrasound-guided continuous adductor canal block provides better postoperative analgesic efficacy following Total knee arthroplasty in patients in the age group 18-80 years?
**HYPOTHESIS**
In total knee arthroplasty, proximal approach of ultrasound-guided continuous adductor canal block provides equivalent postoperative analgesic efficacy as compared to a distal approach.
**AIMS AND OBJECTIVES**
PRIMARY OBJECTIVE
To assess the reduction in postoperative pain at rest in patients with proximal versus distal continuous adductor canal block after total knee arthroplasty at 0, 4, 8, 12 and 24 hours.
SECONDARY OBJECTIVES
1. To assess the 24 hours postoperative total analgesic requirement in patients with proximal versus distal continuous adductor canal block after total knee arthroplasty.
2. To assess the Site of postoperative pain in patients with proximal versus distal continuous adductor canal block after total knee arthroplasty.
3. To assess any catheter associated complication (nausea, vomiting, pruritus, catheter displacement or hematoma at the site of catheter insertion).
**MATERIALS AND METHODS**
STUDY DESIGN
A Comparative Study.
PLACE OF STUDY
Department of Anesthesiology, Lady Hardinge Medical College and Associated Hospitals, New Delhi
STUDY PERIOD
November 2018 to March 2020
STUDY POPULATION
All Patients in the age group 18-80 years undergoing Total Knee Arthroplasty.
INCLUSION CRITERIA
Adult patients planned for Total Knee Arthroplasty.
EXCLUSION CRITERIA
1. Any known drug allergies.
2. Contraindication to nerve block like coagulopathy, bleeding diathesis and local infections.
3. Pre-existing neurological deficit.
SAMPLE SIZE
As per previous records, approximately 70 patients undergoing Total Knee Arthroplasty will be available for enrollment in the study. All Patients undergoing Total knee Arthroplasty fulfilling the inclusion and exclusion will be enrolled for the study, ensuring that a minimum of 30 subjects per group with total sample size of 60 patients will be included in the study.
**METHODOLOGY**
Study will be conducted after approval by the Institutional Ethics Committee. Patients fulfilling the inclusion criteria will included in the study. A careful pre-anesthetic checkup including detailed history, physical examination, baseline hematological investigations and radiological investigations as per clinical requirements will be done. A written informed voluntary consent will be taken from the patient after carefully explaining the procedure, its benefits and risks and alternative therapies in patient’s own language. All patients will be explained about the Visual Analogue Scale for postoperative pain evaluation beforehand.
Randomization and Blinding
An investigator with no further involvement in the study will generate a list of 4 digit random numbers between 1000-9999 in varying block sizes by using an online computer randomization service (Research Randomizer - www.Randomizer.org). The unique randomization code will be allocated and used to randomize consenting participant patients equally with no restrictions or bias to either of the two study groups: Proximal group (I) or distal group (II). The results of the allocation will be concealed in sealed opaque envelopes mentioning the code and the Group no. These envelopes with results of allocation will not be seen by the research coordinator prior to sealing and will only be kept by the coordinator after sealing. On the day of surgery, the coordinator will hand over an envelope to the senior anaesthesiologist supervising the OT. The approach for the block procedure will be decided by the group mentioned in the envelope. Case record sheet filled subsequently will only
mention the randomized code with no reference to the approach or group number noted..
The operated site will be identified and full monitoring and adequate Intravenous access secured. ASA recommended monitoring started. All patients included in the study will undergo Sub-arachnoid block unless contraindicated for intraoperative anesthesia with 0.5% Bupivacaine with anhydrous dextrose (80mg/4ml). Use of General Anaesthesia will be noted if done. Patients will also receive intraoperatively intravenous Dexamethasone 8 mg and intravenous Paracetamol 1000 mg infusion to provide adequate perioperative analgesia. For Group I (Proximal catheter placement), the patient’s lower limb will be kept in a frog-like
position with hips semi-flexed and thigh externally rotated for adequate exposure. A linear high-frequency array ultrasound transducer placed under aseptic precautions at the mid-thigh half-way between the inguinal crease and patella and femoral artery is visualized. An 18G Tuohy’s needle will then be inserted at this point under all aseptic precautions, directing the needle lateral to medial within the plane and placed just lateral to the Femoral Artery at the desired injection site. After careful confirmation of the needle positioning using 0.9% Saline injection, an initial bolus of 30 ml 0.2% Ropivacaine will injected around the artery (perivascular). A flexible 19G Epidural style catheter will now be threaded and advanced 1-2 cm beyond the needle tip into the adductor canal under direct visualization of ultrasound. The needle will be removed and the catheter secured using adequate occlusive dressing. For Group II (Distal catheter placement), similar procedure will be utilized with the exception that the transducer will be slid distally till the Descending genicular artery is seen branching off from the femoral artery. The site of needle placement will be trans-sartorially at the level of visualization of the femoral artery where it goes deep and eventually enters the adductor hiatus . A disposable infusion pump will be used for postoperative continuous local anesthetic infusion via the adductor canal catheter, set initially at 8.0ml/hr of 0.2% Ropivacaine and continued for the next 48 hours.
The dose of local anesthetic used during and after the procedure at 0, 4, 8, 12 and 24 hours will be noted and pain assessments will be done using VAS scores defined as
0=No pain, 1-3=Mild pain, 4-6=Moderate pain, 7-9=Severe pain and 10=extreme pain
Patient will be given IV PCM 1000mg 6 hourly as a part of multimodal analgesic regimen.
Patients will be instructed to ask for rescue opioid analgesics if they report pain of VAS 4 or more using IV Tramadol 2mg/kg.
Site of pain noted as anterior, posterior aspect of knee or both.
Any additional opioid used postoperatively will also be noted.
Any complication (nausea, vomiting, pruritus, catheter displacement or hematoma at the site of injection) will be noted.
The adductor canal catheter will be removed under all aseptic precautions after completion of postoperative 48hrs.
**OUTCOME MEASUREMENT**
Primary Outcome
Mean VAS Score after 24 hours postoperatively in patients receiving continuous local anesthetic infusion via a Proximal or Distal Ultrasound guided Adductor canal catheter.
Secondary Outcome
1. Total 24 hours postoperative analgesics requirements.
2. Site of postoperative pain assessed as involvement of anterior and/or posterior aspect of knee at the time of maximal pain.
3. Frequency of any complications (Nausea, vomiting, pruritus, catheter displacement or hematoma at site of catheter insertion)
**STATISTICAL ANALYSIS**
1. Statistical Package for Social Sciences (SPSS) version 16.0 or above will be used for
analysis
2. The quantitative variables will be expressed as Mean±SD and evaluated using ANOVA
and/or unpaired t-test.
3. α error will be kept at <0.05 and Power (1-β) kept at >80%.
4. A p-value < 0.05 will be assumed statistically significant.
**ETHICAL ISSUES**
1. The study will be done after approval from the Institutional ethical Committee.
2. Written informed consent will be taken from all participants/ caregivers of the study.
3. Both Distal and Proximal Approaches of Ultrasound guided adductor canal block have
been studied and found to be safe and efficacious.
4. Priority will be given to patient management and appropriate treatment and referrals shall
be made.
5. All information shall be kept confidential.
6. Subjects shall have the right to withdraw any time which will have no bearing on the
treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
Adult patients planned for Total Knee Arthroplasty.
- Any known drug allergies.
- Contraindication to nerve block like coagulopathy, bleeding diathesis and local infections.
- Pre-existing neurological deficit.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean VAS Score after 24 hours postoperatively in patients receiving continuous local At 0 hour, 4 hours, 8 hours, 12 hours, 24 hours postoperatively anesthetic infusion via a Proximal or Distal Ultrasound guided Adductor canal catheter. At 0 hour, 4 hours, 8 hours, 12 hours, 24 hours postoperatively
- Secondary Outcome Measures
Name Time Method Site of postoperative pain assessed as involvement of anterior and/or posterior aspect of knee at the time of maximal pain. Total 24 hours postoperative analgesics requirements. At 0 hour, 4 hours, 8 hours, 12 hours, 24 hours postoperatively Frequency of any complications (Nausea, vomiting, pruritus, catheter displacement or hematoma at site of catheter insertion)
Trial Locations
- Locations (1)
Lady Hardinge Medical College and SSKH
🇮🇳Delhi, DELHI, India
Lady Hardinge Medical College and SSKH🇮🇳Delhi, DELHI, IndiaVishal AroraPrincipal investigator9716942642vishalarora.mamc@gmail.com