iPACK Block With Dexamethasone For Total Knee Replacement
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ClinicalTrials.gov Identifier: NCT04917055 |
Recruitment Status :
Recruiting
First Posted : June 8, 2021
Last Update Posted : June 9, 2022
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Comparing the pain control outcomes for patients undergoing total knee arthroplasty (TKA) with either: 1) adductor canal single shot injection plus placebo iPACK injection or 2) adductor canal single shot injection plus bupivacaine and dexamethasone iPACK injection.
There are two surgical approaches for TKA 1) open 2) ROSA robotic assisted. Both follow the same pain management pathway. We plan to enroll patient undergoing either surgical procedure.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Knee Osteoarthritis Acute Pain Anesthesia, Local Regional Anesthesia | Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone Drug: Saline | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Care provider and investigator will know if patient received SHAM or bupivacaine iPACK, but everyone else will be blinded |
Primary Purpose: | Treatment |
Official Title: | Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty |
Actual Study Start Date : | June 7, 2021 |
Estimated Primary Completion Date : | June 7, 2022 |
Estimated Study Completion Date : | August 1, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Active Treatment
Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus distal iPACK (between femoral condyles) single shot with long acting local anesthetic (ropivacaine) plus dexamethasone
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Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone
Regional Nerve block behind the knee for posterior knee pain following total knee arthroplasty using ultrasound guidance, to be done distally between femoral chondyles |
Placebo Comparator: Placebo
Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus iPACK single shot with normal saline
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Drug: Saline
Injection of Saline behind knee using ultrasound guidance |
- Average Opioid Use POD 0-1 [ Time Frame: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement ]Average Opioid Use
- Average Pain Score at Rest [ Time Frame: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement ]Average Pain Score at Rest
- Average Pain Score with Motion [ Time Frame: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement ]Average Pain Score with Motion
- Gait Distance [ Time Frame: POD0-1 (first PT session) ]Distance patient can walk on with physical therapy (PT)
- Knee Range of motion [ Time Frame: POD0-1 (first PT session) ]Range of motion with Physical Therapy (PT)
- Length of stay [ Time Frame: Total number of days requiring hospitalization for surgical procedure. Up to 1 month ]From admission to hospital for surgery to discharge
- Average Opioid Use postoperative day (POD) 1-2 [ Time Frame: Postoperative day (POD) 1-2. ]Average Opioid Use in morphine equivalents
- Average Pain Score, postoperative day (POD) 1-2. [ Time Frame: Postoperative day (POD) 1-2. ]Average Pain Score

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Having total knee arthroplasty at UC San Diego
- Plan to receive single shot adductor canal injection preoperatively
- Plan to receive spinal anesthetic with or without sedation for TKA surgery
Exclusion Criteria:
- Pregnancy
- Inability to communicate with anesthesia provider and/or investigators
- Severe renal, hepatic, cardiac disease
- Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
- BMI > 45 kg/m2
- Allergy to study medications (lidocaine, bupivacaine)
- Incarceration

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917055
Contact: Engy Said, MD | 6195436240 | esaid@health.ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Engy M Said, MD |
Principal Investigator: | Engy Said, MD | University of California, San Diego |
Responsible Party: | Engy T. Said, MD, Clinical Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT04917055 |
Other Study ID Numbers: |
210102 |
First Posted: | June 8, 2021 Key Record Dates |
Last Update Posted: | June 9, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
acute postoperative pain knee replacement |
Osteoarthritis, Knee Acute Pain Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pain Neurologic Manifestations Dexamethasone Epinephrine Ropivacaine Anti-Inflammatory Agents Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |