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Completed

NCT Number: NCT06888349

The Effect of Combined IPACK Block with ACB Versus ACB Alone on Pain Management and Early Mobility After Total Knee Arthroplasty

This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, 00202, Egypt

About this study

This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .All patients were subjected to full history taking including current medications and thorough physical examination.

Age, sex, BMI and ASA physical status were recorded and Preoperative investigations were done to all patients including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and activated partial thromboplastin time) and other investigations according to the patient's medical condition. The patients were fasting for 2 to 8 hours preoperatively. All patients were consented with a written consent for the spinal anesthesia and either of the peripheral regional blocks that were held after explaining the procedure. Intraoperatively, All patients were monitored by pulse oximeter, non-invasive blood pressure cuff and electrocardiogram for heart rate and rhythm. IV Access was applied. All patients received 0.03 mg/kg midazolam iv, granisetron 1mg iv and dexamethasone 10 mg iv as a prophylaxis against nausea and vomiting.Sign IN and Time OUT checklist were revised before starting the anesthetic procedure and the surgical procedure, respectively.All patients received spinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space.All patients received Intraoperative fluids and sedation with intravenous dexmedetomidine if needed.Checking on the availability of intralipid (lipid emulsion 20%) nearby and preparation of the ultrasound device (investigators used in the recent study the Sonosite M-Turbo C Portable Ultrasound). After patients' stabilization, Patients were divided into 2 group.

Group A: received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

Group B: received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. Postoperatively,All patients were transferred to the post anesthesia care unit (PACU).

All patients were monitored at (PACU) for oxygen saturation, heart rate and blood pressure for 2hours observational period.The two groups of patients were evaluated and compared as regard:

Degree of postoperative pain using Numerical Rating Scale (NRS) at the first 48 hrs. The first need for analgesic rescue (NRS score ≥ 4 [0: no pain 10: very severe pain]) at 2, 4, 6, 8, 12, 24, and 48 hr. and the total amount of analgesic rescues was determined. Analgesic rescue was provided using 1 gram paracetamol IV and 30mg ketorolac IV, while in a few cases titration of pethidine was used after failure of the determined analgesic rescue with paracetamol and ketorolac to provide pain relief.

The recovery of spinal motor blockade and early motor ability using Bromage score and the incidence of peroneal motor weakness (dorsiflexion of the ankle and toes).

Length of hospital stays (defined as the days from the end of surgery until discharge).

The first mobilization time recorded in hours. The Timed Up and Go (TUG)test (measured in seconds).This test was performed on the 1st and 2nd postoperative days.Postoperative 1st and 2nd-day Rang of Movement (ROM) measurements.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sex: Patients of either sex
  • Age: between 45 and 75 years.
  • Physical status: ASA I- III.
  • Weight: BMI between 28-40 kg/m2.
  • Lesion: any patient with knee pathology requiring total knee arthroplasty (TKA)

Exclusion criteria

  • o Body mass index >40 kg/m2.
  • ASA>III.
  • Patient's refusal.
  • Revision knee arthroplasty
  • Bilateral knee arthroplasty.
  • Lack of mental ability to provide informed consent.
  • Neuropathic pain or sensory disorders of the surgical limb.
  • Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block).

Treatment and study plan

Spinal anesthesia

Procedure

spinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space.

Adductor canal block

Procedure

local anesthetic spread around the saphenous nerve in the adductor canal ultrasound guided using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

interspace between Popliteal artery and capsule of knee (IPACK) block

Procedure

ultrasound guided Local anesthetic infiltration over the posterior aspect of the femur underneath the popliteal artery targeting the genicular nerves which are the articular branches of tibial and common peroneal nerves, posterior branches of the obturator nerve, and medial genicular nerve using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

Primary outcomes

  1. postoperative pain degree

    Time frame: 48hours

    two groups of patients were evaluated and compared as regard the Degree of postoperative pain using Numerical Rating Scale (NRS) which consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" and 10 being "the worst pain imaginable.", So that the higher the number the worse is the pain . The numerical rating scale is recorded each 4hours at the first 48 hours.

  2. The first time to need analgesic rescue .

    Time frame: 2days

    The first time to need analgesic rescue when (Numerical rating scale score

    ≥ 4 which means moderate to severe pain ) is recorded in hours (the Numerical rating scale consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" 1to3 being "mild pain,4to6 being "moderate pain "and 7to10 being "sever pain" . So that the higher the number the worse is the pain.

  3. the total amount of analgesic rescues needed measured in numbers

    Time frame: 2days

    Number of analgesic rescues needed when patient's pain is moderate to sever

Secondary outcomes

  1. Sex influence on degree of pain

    Time frame: At the time of patients' enrollment in the study.

    Two groups were compared as regard number of males and females in each group

  2. Age

    Time frame: At the time of patients' enrollment in the study.

    The ages of patients in each group were recoded and compared .

  3. BMI(kg/m2)

    Time frame: At the time of patients'enrollment in the study.

    BMI of each patient was recorded and the two groups were compared .

  4. Motor recovery

    Time frame: 2days

    Motor recovery after spinal anesthesia blockade Determined by Bromage score done using clinical assessment of motor ability . Bromage a score is score of four levels where score 1 = free movement of legs and feet; score 2 = just able to flex knees with free movement of feet; score 3 = unable to flex knees, but with free movement of feet; and score 4 = unable to move legs or feet.so that score 4 means no motor recovery with complete motor blockade and a(the minimum value) and score 1 means complete motor recovery with no blockade (the maximum value)

  5. Mobility recovery

    Time frame: 2days

    Timed up and go test is done for each patient assessing the ability and the time it takes the patient to move up from a chair and wake for three meters then get back to the chair and is recorded in seconds .

  6. Degree of motor recovery

    Time frame: 2days

    Range of motion test is done for each patient assessing the extension and flexion ability of the knee with measuring and recording the degree of angle in between .

  7. Fast recovery and early hospital discharge

    Time frame: 48hours

    Duration of hospital stay is recorded in hours for each patient , so that the patient with hospital stay duration beyond 48hours is considered of delayed rehabilitation and prolonged hospital stay .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Combined IPACK(Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block with Adductor Canal Block Versus Adductor Canal Block Alone on Pain Management and Early Mobility After Total Knee Arthroplasty

Acronym: IPACK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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