A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty

Nanjing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Unilateral Knee Arthroplasty; Postoperative Recovery; Liposomal Bupivacaine

Treatments: Other: Intravenous analgesia; Combination Product: Nerve block with liposomal bupivacaine and intravenous analgesia; Other: Nerve block with ropivacaine and intravenous analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06145165

KY20230829-05

Details and patient eligibility

About

To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty

Full description

The pain after knee arthroplasty limits the patient's activities and postoperative recovery, and currently there are mainly three analgesic methods: intravenous analgesia, epidural analgesia and nerve block analgesia. There is a lack of studies on whether liposomal bupivacaine, if used for ACB and iPACK block, can achieve benefits in knee arthroplasty pain management by prolonging sensory nerve block without affecting muscle strength, improving patient prognosis, and shortening hospitalization days.

In this study, in order to better evaluate the effect of liposomal bupivacaine for ACB and iPACK biock on the prognosis of patients undergoing knee arthroplasty, not only the NRS and AUC of patients in each group will be observed, but also the postoperative QoR-15 Quality of Recovery Rating Scale, postoperative nausea, vomiting and other complications, and the number of hospitalization days will be also included as observation indicators. The completion of this study can provide a clinical basis for the selection of analgesic regimens for knee arthroplasty, and also provide strong evidence-based medical support for the relevant medical decision making of government departments.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-79 years.
2. Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
3. Normal diet.
4. ASA grade I~Ⅲ;
5. BMI 18-30kg /m2.
6. No intraspinal anesthesia contraindications.

Exclusion criteria

1. Patients with severe neurological diseases.
2. Hearing and speech impaired.
3. Preoperative gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery, etc.
4. Patients with severe renal insufficiency or other severe metabolic diseases.
5. Mental disorders, alcoholism or a history of drug abuse.
6. The surgical time is greater than 3 hours.
7. Puncture site infection, abnormal coagulation function, and local anesthetic allergy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

RP group:Nerve block with ropivacaine and intravenous analgesia group

Placebo Comparator group

Description:

The ropivacaine group will use ultrasound high-frequency line array probe for ACB and convex array probe for iPACK block before induction of general anesthesia

Treatment:

Other: Nerve block with ropivacaine and intravenous analgesia

LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group

Experimental group

Description:

The liposomal bupivacaine group will use ultrasound high-frequency line array probe for ACB and convex array probe for iPACK block before induction of general anesthesia

Treatment:

Combination Product: Nerve block with liposomal bupivacaine and intravenous analgesia

control group：Intravenous analgesia group

Placebo Comparator group

Description:

General anesthesia was induced directly

Treatment:

Other: Intravenous analgesia