Pain Management After Adductor Canal Block for Total Knee Arthroplasty

• Sponsor: Poznan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT06086483
• Collaborator: (none)
• Enrollment: 361
• Location: 1
• Arms: 2
• Actual Duration (Months): 38.2
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy; Knee Pain Chronic	Drug: Ropivacaine 0.2% Injectable Solution; Drug: 0.9%sodium chloride	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 361 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, double-blind, placebo-controlledrandomized, double-blind, placebo-controlled
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.
• Actual Study Start Date: Jun 18, 2020
• Actual Primary Completion Date: Jul 20, 2022
• Actual Study Completion Date: Aug 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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; Other Names: Ropimol
Active Comparator: 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.	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; Other Names: normal saline

Outcome Measures

Primary Outcome Measures

1. postoperative Numeric Pain Rating Scale [24 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

2. postoperative Numeric Pain Rating Scale et rest [48 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

3. postoperative Numeric Pain Rating Scale et rest [72 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

4. postoperative Numeric Pain Rating Scale et rest [96 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

5. postoperative Numeric Pain Rating Scale during active flexion [48 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

6. postoperative Numeric Pain Rating Scale during active flexion [72 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

7. postoperative Numeric Pain Rating Scale during active flexion [96 hours after surgery]

   Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Secondary Outcome Measures

1. Postoperative opioid consumption [96 hours after surgery]

   milligrams of intravenous morphine equivalents

2. Neutrophil-to-lymphocyte ratio [12 hours after surgery]

   Neutrophil-to-lymphocyte ratio

3. Neutrophil-to-lymphocyte ratio [24 hours after surgery]

   Neutrophil-to-lymphocyte ratio

4. Platelet-to-lymphocyte ratio [12 hours after surgery]

   Platelet-to-lymphocyte ratio

5. Platelet-to-lymphocyte ratio [24 hours after surgery]

   Platelet-to-lymphocyte ratio

6. Time to first opioid administration [96 hours postoperatively]

   Hours to first administration of an intravenous opioid drug

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• refusal to participate

• < 18 yo

• Chronic opioid use

• localized infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poznan University of Medical Sciences	Poznan	Poznań	Poland	61-701

Sponsors and Collaborators

• Poznan University of Medical Sciences

Investigators

• Study Chair: Zbigniew Żaba, Ph.D., Department of Emergency Medicine Clinic
• Principal Investigator: Malgorzata Domagalska, Ph.D., Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poznan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT06086483
• Other Study ID Numbers: 495/2020
• First Posted: Oct 17, 2023
• Last Update Posted: Oct 17, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Poznan University of Medical Sciences: iPACK; Adductor Canal Block; pain management; multimodal analgesia; peripheral nerve block; knee arthroplasty
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Ropivacaine

Study Results

No Results Posted as of Oct 17, 2023