An interventional study of Methylprednisolone Injection and Bupivacaine Hcl 0.5% Inj_#2 in Postoperative Pain, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
This study is designed to test the efficacy of adding Depomedrol a long-acting steroid to bupivacaine for relieving postoperative pain and reducing opioid requirements following total knee replacement surgery. For this purpose, Depomedrol will be added to bupivacaine for ultrasound-guided Genicular nerve block combined with spinal anesthesia.
TKA remains a challenge for physicians as more than half of these patients experience extreme knee pain immediately after surgery. The management of pain in patients undergoing total knee arthroplasty (TKA) remains a challenge for the anesthesiologist even with regional anesthesia as no single regional technique is adequate to balance effective analgesia with minimal muscle weakness. Severe postoperative pain following TKA has been shown to negatively affect early mobilization, physical rehabilitation, time to discharge, and overall post-op recovery. Multimodal analgesia incorporating regional anesthesia techniques provides optimum analgesia and minimizes the use of opioids and their side effects. Proximal nerve blocks such as the lumbar plexus, femoral nerve, and proximal sciatic nerve blocks provide excellent analgesia but frequently cause motor weakness, which reduces the patient's mobility. A distal blockade of genicular branches has also been described using ultrasound in acute and chronic pain management with fewer side effects. The superior medial genicular nerve and lateral genicular nerve can be identified using ultrasound and blocked at the level of the medial intramuscular, and lateral femoral epicondyles deep to the vastus medialis and lateralis, respectively. The inferior medial genicular nerve can be also targeted medial to the tibial plateau adjacent to the genicular vessels. Methylprednisolone acetate (MPA)(Depomedrol) is a lipophilic glucocorticoid commonly used in chronic pain procedures. It has a good safety record and its analgesic action can last from days to weeks.(8) The literature supporting its role as an adjuvant to local anesthetic in peripheral nerve block are scanty. However, some studies showed that depo-methylprednisolone as an adjuvant to 0.5% lidocaine showed excellent results in neuropathic pain resulting from nerve injury. This study aims to evaluate the efficacy of adding depomedrol as an additive to bupivacaine in genicular nerve block for evaluating postoperative pain, opioid use, and ease of ambulation in patients undergoing TKA.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 48 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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With ultrasound guidance, 20 ml plain normal saline will be injected to spread lateral to the femoral artery and deep to the sartorius muscle, or more distal, below the knee after arrival to the theatre.
Drug: normal saline
With ultrasound guidance, a mixture of 5 ml Bupivacaine 0.5%, 1 ml (20 mg) depomedrol, and 14 ml normal saline is injected to spread lateral to the femoral artery and deep to the sartorius muscle, or more distal, below the knee after arrival at the theatre.
Drug: Methylprednisolone Injection · Drug: Bupivacaine Hcl 0.5% Inj_#2 · Drug: normal saline
A mixture of 5 ml Bupivacaine 0.5%- and 14-ml normal saline is injected to spread lateral to the femoral artery and deep to the sartorius muscle, or more distal, below the knee, after arrival at the theatre.
Drug: Bupivacaine Hcl 0.5% Inj_#2 · Drug: normal saline
Ultrasound-guided genicular nerve block comparing Methylprednisolone combined with Bupivacaine to bupivacaine alone. All patients will undergo TKA and will receive spinal anesthesia.
Also known as: Depomedrol
Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline
Also known as: Marcaine 0.5%
Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.
Also known as: 0.9% saline
Postoperative pain
will be assessed postoperatively using 10 points numerical rating scale (NRS) where 0 no pain and 10 is the most intense pain. The median of pain scores through 48 hours will be compared.
Time frame: 48 hours.
Opioid consumption
The amounts of Morphine in milligrams required by each patient will be recorded and compared.
Time frame: 24 hours, 48 hours.
Ambulation distance
The distance in meters that every patient can move without stopping pain.
Time frame: Day one, day2 and day3
Plan to share: Yes — all of the individual participant data collected during the trial after deidentification.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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