ACB With S-ESPB Versus ACB With iPACK for Knee Arthroplasty

NCT07288970 | Recruiting

• 1 other identifier: 11/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two regional anesthesia strategies for pain management after total knee arthroplasty in adults. Both strategies use an adductor canal block (ACB) to provide analgesia while preserving quadriceps muscle strength. The ACB is then combined with either a sacral erector spinae plane block (S-ESPB) or an iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block to improve posterior knee analgesia. All patients will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of two groups: Group 1: ACB combined with a sacral erector spinae plane block (S-ESPB) using 20 mL of 0.2% ropivacaine. Group 2: ACB combined with an iPACK block using 20 mL of 0.2% ropivacaine. Both techniques aim to provide effective postoperative analgesia while minimizing motor blockade and allowing for early mobilization. It is not known whether combining ACB with S-ESPB or with iPACK provides superior pain control, reduces opioid requirements, or results in better functional recovery after total knee arthroplasty. The main purpose of this study is to compare the time to first rescue analgesia and overall postoperative pain control between the two regional anesthesia strategies. The study will also evaluate opioid consumption, motor function, functional mobility, side effects, and block-related complications. We hypothesize that both combinations will provide effective analgesia, but their impact on pain intensity, duration of analgesia, and functional recovery may differ.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Time to First Rescue Analgesia

  Time (in hours) from completion of the regional blocks to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).

  Within 48 hours after surgery.

Secondary Outcomes (19)

• Pain Intensity at Rest (NRS 0-10)

  4 hours after surgery.

• Pain Intensity at Rest (NRS 0-10)

  8 hours after surgery.

• Pain Intensity at Rest (NRS 0-10)

  12 hours after surgery.

• Pain Intensity at Rest (NRS 0-10)

  24 hours after surgery.

• Pain Intensity at Rest (NRS 0-10)

  48 hours after surgery.

Study Arms (2)

Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB)

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and a sacral erector spinae plane block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia.

Procedure: Adductor Canal Block; Procedure: Sacral Erector Spinae Plane Block

Adductor Canal Block Plus iPACK Block (ACB + iPACK)

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine and an iPACK block with 20 mL of 0.2% ropivacaine. All patients will receive standard perioperative care and multimodal analgesia.

Procedure: Adductor Canal Block; Procedure: iPACK Block

Interventions

Sacral Erector Spinae Plane Block PROCEDURE

Ultrasound-guided sacral erector spinae plane block performed with 20 mL of 0.2% ropivacaine injected deep to the erector spinae muscle at the sacral level. Used in combination with ACB in the ACB + S-ESPB group.

Also known as: S-ESPB; Sacral ESP block

Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB)

iPACK Block PROCEDURE

Ultrasound-guided iPACK block performed with 20 mL of 0.2% ropivacaine injected between the popliteal artery and the posterior capsule of the knee. Used in combination with ACB in the ACB + iPACK group.

Also known as: Infiltration between the popliteal artery and the posterior capsule of the knee

Adductor Canal Block Plus iPACK Block (ACB + iPACK)

Adductor Canal Block PROCEDURE

Ultrasound-guided adductor canal block performed with 20 mL of 0.2% ropivacaine injected around the saphenous nerve within the adductor canal. Used in both study arms as part of the regional anesthesia protocol for total knee arthroplasty.

Also known as: ACB

Adductor Canal Block Plus Sacral Erector Spinae Plane Block (ACB + S-ESPB); Adductor Canal Block Plus iPACK Block (ACB + iPACK)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Scheduled for elective unilateral total knee arthroplasty under spinal or general anesthesia
• ASA physical status I-III
• Planned use of regional anesthesia with an adductor canal block as part of multimodal analgesia
• Ability to communicate pain intensity using the NRS scale
• Written informed consent obtained from the patient

You may not qualify if:

• Refusal or inability to provide informed consent
• Allergy, intolerance, or contraindication to local anesthetics (ropivacaine)
• Pre-existing significant neurological deficit or neuropathy in the operative limb
• Coagulopathy or anticoagulation that contraindicates peripheral nerve blocks (e.g., INR \>1.5, platelets \<100,000/µL, or therapeutic anticoagulation that cannot be safely paused)
• Infection at or near the planned needle insertion sites
• Severe hepatic or renal impairment
• Chronic opioid therapy (\>30 days of daily opioid use before surgery)
• Cognitive impairment or delirium preventing reliable pain assessment BMI \> 40 kg/m² (optional - if chcesz ograniczyć ze względu na trudność USG)
• Previous knee arthroplasty on the same side or revision TKA (jeśli chcesz tylko primary TKA)
• Pregnancy or breastfeeding
• Participation in another interventional clinical trial within 30 days

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48618738313; mreysner@ump.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study blocks will be performed by an anesthesiologist who is not involved in intraoperative management or postoperative outcome assessment. Study medications and syringes will be prepared by a clinician not involved in patient care. All participants will receive identical appearing syringes, and all blocks will be performed under ultrasound guidance in a standardized fashion. Patients, surgeons, ward staff, investigators, and outcome assessors will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months after publication, available for 5 years
• Access Criteria: upon reasonable request; de-identified data; DSA if needed

Locations

PL (1)