Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Location contact
Afua Gyamfi, MD
CONTACT
Afua Gyamfi, MD
PRINCIPAL_INVESTIGATOR
James Turner, MD
CONTACT
James Turner, MD
SUB_INVESTIGATOR
NCT Number: NCT07097493
The purpose of this research study is to compare two different combinations of anesthetic medications to see which works the best in providing the longest lasting pain relief for total knee arthroplasty surgery. The drugs being used are liposomal bupivacaine compared to a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Pain scores will be collected at different intervals during study participation.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Winston-Salem, North Carolina, 27157, United States
Afua Gyamfi, MD
CONTACT
Afua Gyamfi, MD
PRINCIPAL_INVESTIGATOR
James Turner, MD
CONTACT
James Turner, MD
SUB_INVESTIGATOR
This double-blinded prospective randomized control trial will evaluate analgesia following total knee arthroplasty for patients who receive an adductor canal block and infiltration between the popliteal artery and condyles of the knee (iPACK) block utilizing bupivacaine with the adjuvants clonidine, epinephrine, buprenorphine and dexamethasone (BPV-CEBD), as compared to patients who receive liposomal bupivacaine (LB) for both blocks.
All patients will receive a spinal anesthetic with ropivacaine (17.5 mg) and fentanyl (10 mcg), and an adductor canal and iPACK block for analgesia. Patients randomized to the LB group will receive 10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of LB into both the adductor canal and iPACK blocks (total of 40 ml). The BPV-CEBD group will receive a 20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone - which will be used in both the adductor canal block and iPACK block (total of 40 ml).
On post-operative day (POD) 0, rest and movement pain scores will be collected at 4 hours and 8 hours with time "zero" being the time of the final block placement. On POD 1 and 2, questionnaires will be collected for pain scores at 0700, 1200 and 1700. Participants will be called once daily on days 3 through 7 to collect remaining secondary data, including sleep score, quality of recovery, worst daily pain score, and patient satisfaction (POD 7 only).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of liposomal bupivacaine into both the adductor canal and iPACK blocks (total of 40 ml)
20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone which will be used in both the adductor canal block and iPACK block (total of 40 ml)
Time frame: Baseline
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Hour 4 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Hour 8 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Hour 48 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Hour 72 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Hour 72 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Postop Days 3, 4, 5, 6, 7
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Time frame: Hour 48 post final block placement
all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 2
Time frame: Hour 72 post final block placement
all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 3
Time frame: Postop Days 3, 4, 5, 6, 7
quality of life questions rated on a 0-10 scale for 0=none of the time up to 10=all of the time on a daily basis; pain/nausea/vomiting/depression questions answered in a 10=none of the time down to a 0=all of the time (scales reversed on that scale)
Time frame: 24 hours
distance (feet) walked during first physical therapy appointment
Time frame: Postop Days 3, 4, 5, 6, 7
quality of sleep rated on a scale of 0=very poor/not at all up to 5=very good/very much
Time frame: Postop Day 7
measured with a 5-point Likert scale 0=not satisfied at all up to 5=best level of satisfaction
Time frame: Up to Postop Day 7
overall number of nausea occurrences
Time frame: Up to Postop Day 7
overall number of vomiting occurrences
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06357013
Agnosia, Knee Arthroplasty, Total
Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT07110324
Hip Arthroplasty Replacement, Knee Arthroplasty, Total
Østerbro, København Ø, Denmark
View Trial DetailsNCT07425457
Agnosia, Arthroplasty
Athens, Greece
View Trial DetailsNCT07410884
Knee Arthroplasty, Total, Knee Osteoarthristis
Mihara, Japan
View Trial Details