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

Phase 1

Recruiting

• Conditions: Liposomal Bupivacaine; Postoperative Recovery; Unilateral Knee Arthroplasty
• Interventions: Other: Nerve block with ropivacaine and intravenous analgesia; Other: Intravenous analgesia; Combination Product: Nerve block with liposomal bupivacaine and intravenous analgesia

• Registration Number: NCT06145165
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-27
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-24
• Last Update Posted: 2023-11-24
• Study Start: 2023-12-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RP group:Nerve block with ropivacaine and intravenous analgesia group	Nerve block with ropivacaine and intravenous analgesia	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
control group：Intravenous analgesia group	Intravenous analgesia	General anesthesia was induced directly
LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group	Nerve block with liposomal bupivacaine and intravenous analgesia	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

Primary Outcome Measures

Name	Time	Method
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group	Up to 48 hours postoperative	To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty.A lower dose of analgesics indicates a longer duration of block.

Secondary Outcome Measures

Name	Time	Method
NRS scores at rest and during exerciseat at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative	at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative	The NRS typically consists of a straight line with numbers ranging from 0 to 10. Each number corresponds to a level of pain intensity:0: No pain.1 to 3: Mild pain （low intensity）. 4 to 6: Moderate pain （moderate intensity）. 7 to 10: Severe pain (high intensity) Patients are asked to choose a number that best represents their current pain level, where 0 means no pain, and 10 indicates the worst possible pain.A lower NRS score indicates a longer duration of block.
The total number of PCIA compressions on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	Fewer total PCIA compressions indicated a longer duration of block.
The number of effective PCIA compressions on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	Fewer total effective PCIA compressions indicated a longer duration of block.
The number of times of remedial analgesia on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	Fewer times of rescue analgesia indicated a longer duration of analgesia.
The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	Less cumulative use of analgesics indicates a longer duration of block
The percentage of subjects who did not use remedial analgesics on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	A greater percentage of subjects who did not use rescue analgesics indicated a longer duration of analgesic block.
Satisfaction score of subjects on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Satisfaction score of surgeons on the first day,the second day and the third day after surgery.	On the first day,the second day and the third day after surgery.	Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Both the liposomal bupivacaine group and the ropivacaine group were subjected to ACB and iPACK block. Area under the pain intensity-time curve within 72 hours after the first postoperative dose(PI-AUC72)was observed in the three groups.	within 72 hours after the first postoperative initiation of drug administration	A smaller PI-AUC72 indicates a longer duration of nerve block.
15-item Quality of Recovery Rating Scale (QoR-15): 24hours, 48hours and 72hours postoperatively	at 24 hours, 48 hours and 72 hours postoperative	QoR-15 was used to assess five aspects of postoperative recovery quality (physical comfort, physical independence, psychological support, emotion and pain), with higher scores indicating the higher postoperative recovery quality. The lowest score is 0 points, and the highest score is 150 points.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China