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

NCT06888349 | Completed

• 1 other identifier: FMASU MD 19/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Postoperative Pain; Motor Activity

Keywords

Postoperative pain; Early rehabilitation

Outcome Measures

Primary Outcomes (3)

• postoperative pain degree

  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.

  48hours

• The first time to need analgesic rescue .

  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.

  2days

• the total amount of analgesic rescues needed measured in numbers

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

  2days

Secondary Outcomes (7)

• Sex influence on degree of pain

  At the time of patients' enrollment in the study.

• Age

  At the time of patients' enrollment in the study.

• BMI(kg/m2)

  At the time of patients'enrollment in the study.

• Motor recovery

  2days

• Mobility recovery

  2days

Study Arms (2)

adductor canal block (ACB) alone

ACTIVE COMPARATOR

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.

Procedure: spinal anesthesia; Procedure: Adductor Canal Block

adductor canal block (ACB)in addition to (IPACK) block

ACTIVE COMPARATOR

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.

Procedure: spinal anesthesia; Procedure: Adductor Canal Block; Procedure: interspace between Popliteal artery and capsule of knee (IPACK) block

Interventions

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 (ACB) alone; adductor canal block (ACB)in addition to (IPACK) block

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.

adductor canal block (ACB) alone; adductor canal block (ACB)in addition to (IPACK) block

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.

adductor canal block (ACB)in addition to (IPACK) block

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Motor Activity

Interventions

Anesthesia, Spinal; Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Arm1: received ultrasound guided adductor canal block (ACB) alone . Arm2: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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Esraa Alaa(Assistant lecturer at anesthesia,ICU and pain department of faculty of medicine/ Ain shams university

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 21, 2025
• Study Start: January 23, 2023
• Primary Completion: January 8, 2024
• Study Completion: February 8, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)