Clinical trial NCT05447871: Single-injection Modified 4 in 1 Block as Postoperative Analgesia in Total Knee Arthroplasty
Official title: Single-injection Modified 4 in 1 Block Versus Adductor Canal Block as Postoperative Analgesia in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients suffer from moderate to severe pain after TKA. Patients are asked to begin functional exercise as early as possible after surgery, and that requires adequate control of postoperative pain. Regional anesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK but these blocks have many drawbacks.

So new studies found that a modified 4 in-1 block blocks all these nerves and produces adequate analgesia without sparing areas.

Detailed description: Total knee arthroplasty (TKA) is regarded as the most effective method to reduce knee pain and improve knee function in patients with advanced knee osteoarthritis. Postoperative pain is an unpleasant experience for TKA and this pain might greatly influence patients' early rehabilitation.

Almost 60% of patients suffer moderate to severe pain after TKA and 25% of them could even develop related complications, such as longer hospitalization stays, unanticipated hospital admissions, readmissions, etc.

With the development of enhanced recovery after surgery, patients are asked to begin exercise as early as possible after surgery, and that requires adequate control of postoperative pain.

Multimodal systemic analgesia plays an essential role in controlling postoperative pain after TKA by controlling the inflammatory process, dealing with the neuropathic component of pain, and thus reducing the severity of pain.

Multimodal analgesia includes more than one pain-control modality (systemic analgesia and regional anaesthesia). Systemic analgesia includes acetaminophen, nonsteroidal anti-inflammatory drugs, steroids and opioids. Regional anaesthesia includes epidural analgesia, femoral n. block, adductor canal block, sciatic n. block, IPACK, etc. Regional anaesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK.

But these blocks have many drawbacks. Femoral n. block is associated with quadriceps muscle weakness leading to delay in patient's mobility. Sciatic n. block also causes foot drop. The Adductor canal block does not cover the skin on the back of the knee. Surgeons refuse IPACK because of diffusion of local anaesthetics disturbs the anatomy of the surgical field.

The Modified 4 in 1 block technique aims to block four nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) through a single injection point by spreading up to the adductor canal in midthigh and below to the popliteal fossa. The investigator will conduct this randomized clinical trial to evaluate the quality of postoperative analgesia produced by a single injection modified 4 in 1 block and midsartorius adductor canal block with regard to total analgesic consumption in the first 24 hours postoperatively

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 19-30 kg/m2
* American Society of Anesthesiologists (ASA) functional status of I-III

Exclusion Criteria:

* Drug hypersensitivity
* coagulopathy
* infection at the site of injection
* Traumatic arthirits

Primary outcomes:
measure: Total amount of postoperative analgesia in first 24 hours
timeFrame: in first 24 hours
Secondary outcomes:
measure: Duration of sensory block.
timeFrame: 3, 6, 12, 24 hours postoperative
measure: Duration of motor block.
timeFrame: 3, 6, 12, 24 hours postoperative
measure: Total distance patient will be able to ambulate on first postoperative day
timeFrame: on first postoperative day
measure: intraoperative non invasive blood pressure(NIBP) mmHg
timeFrame: every 10 minutes after spinal anesthesia till the end of the surgery
measure: intraoperative heart rate beat per minute
timeFrame: every 10 minutes after spinal anesthesia till the end of the surgery.
measure: postoperative hypotension mmHg
timeFrame: at 1, 3, 6, 12 hours postoperative
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Gehan A Trabeeh, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Samah A Gouda, MD
role: STUDY_DIRECTOR
affiliation: Assistant lecturer of Anesthesia and Surgical Intensive Care
name: Samar A Alattar, M.Sec
role: PRINCIPAL_INVESTIGATOR
References: