Pain Management After Adductor Canal Block for Total Knee Arthroplasty

NCT ID: NCT06086483

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2023-08-24

Brief Summary

This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.

Detailed Description

The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

iPACK block+ABC block

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

20 mL 0.5% ropivacaine was injected into the PENG block

20 mL 0.5% ropivacaine was injected into the Adductor Canal block

Sham blocks

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.

Group Type: ACTIVE_COMPARATOR

0.9%sodium chloride

Intervention Type: DRUG

20 mL 0.9% sodium chloride was injected into the PENG block

20 mL 0.5% sodium chloride was injected into the Adductor Canal block

Interventions

Ropivacaine 0.2% Injectable Solution

20 mL 0.5% ropivacaine was injected into the PENG block

20 mL 0.5% ropivacaine was injected into the Adductor Canal block

Intervention Type: DRUG

0.9%sodium chloride

20 mL 0.9% sodium chloride was injected into the PENG block

20 mL 0.5% sodium chloride was injected into the Adductor Canal block

Intervention Type: DRUG

Other Intervention Names

Ropimol; normal saline

Eligibility Criteria

Inclusion Criteria

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria

• refusal to participate
• < 18 yo
• Chronic opioid use
• localized infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zbigniew Żaba, Ph.D.

Role: STUDY_CHAIR

Department of Emergency Medicine Clinic

Malgorzata Domagalska, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

Locations

Poznan University of Medical Sciences

Poznan, Poznań, Poland

Countries

Poland

Other Identifiers

495/2020

Identifier Type: -

Identifier Source: org_study_id