IPACK Nerve Block for Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-17

Study Completion Date

2018-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.

Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)

NCT03094663

Knee Arthropathy

COMPLETED PHASE4

The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

NCT03703206

Knee Arthroplasty, Total

COMPLETED PHASE3

Pain Management After Adductor Canal Block for Total Knee Arthroplasty

NCT06086483

Knee Osteoarthritis Knee Arthritis Knee Arthropathy +1 more

COMPLETED PHASE4

Comparing Local Anesthesia With and Without iPACK Block

NCT04635176

Osteo Arthritis Knee Analgesia Pain, Postoperative

UNKNOWN PHASE4

Genicular vs IPACK Block for Analgesia in Knee Arthroplasty

NCT07171931

Postoperative Pain Management in Total Knee Arthroplasty

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthropathy of Knee Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Only the regional anesthesiologist performing the block will know the randomization status. The study participants, outcome assessors/researchers, other anesthesia personnel, surgeons, physician assistants, and nurses will be blinded to the treatment arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

continuous ACB with IPACK block

ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.

continuous ACB with sham subcutaneous saline injection

ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh

Group Type SHAM_COMPARATOR

Ropivacaine

Intervention Type DRUG

All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.

Saline

Intervention Type DRUG

All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivacaine

All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.

Intervention Type DRUG

Saline

All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Naropin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Unilateral, primary tricompartment total knee arthroplasty
* Age 18 years or older
* ASA I-III
* Eligible for spinal or combined spinal epidural anesthetic
* Able to speak, read, and understand English
* Willing to participate in the trial

Exclusion Criteria

* Contraindication to regional anesthesia or peripheral nerve blocks
* Allergy to local anesthetics
* Allergy to NSAIDs
* Chronic renal insufficiency with Cr \> 1.4 or GFR \< 60
* Have chronic pain that is not related to their knee joint
* Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)
* Have a pre-existing peripheral neuropathy involving the operative site
* Body mass index greater than or equal to 40

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No