Clinical trial
A Analgesic Study of Adductor Canal &IPACK Block With Liposomal Bupivacaine in Knee Arthroplasty ：A Randomized，Double-controlled，Parallel-controlled，Single-center Study
Name
KY20230829-05
Description
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Nerve block with ropivacaine and intravenous analgesia
When the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3.
Arms:
RP group:Nerve block with ropivacaine and intravenous analgesia group
Nerve block with liposomal bupivacaine and intravenous analgesia
When the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3.
Arms:
LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group
Intravenous analgesia
When the MOAA/S score is 5 after the surgery,the PCIA pump equipped with sufentanil injection will be connected,if the patient's resting NRS ≥ 4 points , they should be given sufentanil 5 ug intravenously at intervals of more than 8 minutes until NRS ≤ 3.
Arms:
control group：Intravenous analgesia group
Size
90
Primary endpoint
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
Up to 48 hours postoperative
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-11-24
1 organization
Organization
Nanjing First Hospital