Clinical trial NCT06145165: A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty
Official title: A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty ：A Randomized，Double-controlled，Parallel-controlled，Single-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liposomal Bupivacaine
Postoperative Recovery
Unilateral Knee Arthroplasty
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
timeFrame: Up to 48 hours postoperative
Secondary outcomes:
measure: 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
timeFrame: at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative
measure: The total number of PCIA compressions on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: The number of effective PCIA compressions on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: The number of times of remedial analgesia on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: The percentage of subjects who did not use remedial analgesics on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: Satisfaction score of subjects on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: Satisfaction score of surgeons on the first day,the second day and the third day after surgery.
timeFrame: On the first day,the second day and the third day after surgery.
measure: 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.
timeFrame: within 72 hours after the first postoperative initiation of drug administration
measure: 15-item Quality of Recovery Rating Scale (QoR-15): 24hours, 48hours and 72hours postoperatively
timeFrame: at 24 hours, 48 hours and 72 hours postoperative
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Liu Han
role: STUDY_CHAIR
References:
citation: Kukreja P, Feinstein J, Kalagara HK, Huntley SR, Lee SR, Naranje S, Shah A. A Summary of the Anatomy and Current Regional Anesthesia Practices for Postoperative Pain Management in Total Knee Arthroplasty. Cureus. 2018 Jun 7;10(6):e2755. doi: 10.7759/cureus.2755.
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citation: Fedriani de Matos JJ, Atienza Carrasco FJ, Diaz Crespo J, Moreno Martin A, Tatsidis Tatsidis P, Torres Morera LM. Effectiveness and safety of continuous ultrasound-guided femoral nerve block versus epidural analgesia after total knee arthroplasty. Rev Esp Anestesiol Reanim. 2017 Feb;64(2):79-85. doi: 10.1016/j.redar.2016.05.008. Epub 2016 Jul 9. English, Spanish.
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citation: Mou P, Wang D, Tang XM, Zeng WN, Zeng Y, Yang J, Zhou ZK. Adductor Canal Block Combined With IPACK Block for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2022 Feb;37(2):259-266. doi: 10.1016/j.arth.2021.10.004. Epub 2021 Oct 13.
citation: Hasabo EA, Assar A, Mahmoud MM, Abdalrahman HA, Ibrahim EA, Hasanin MA, Emam AK, AbdelQadir YH, AbdelAzim AA, Ali AS. Adductor canal block versus femoral nerve block for pain control after total knee arthroplasty: A systematic review and Meta-analysis. Medicine (Baltimore). 2022 Aug 26;101(34):e30110. doi: 10.1097/MD.0000000000030110.
citation: Hussain N, Brull R, Sheehy B, Dasu M, Weaver T, Abdallah FW. Does the addition of iPACK to adductor canal block in the presence or absence of periarticular local anesthetic infiltration improve analgesic and functional outcomes following total knee arthroplasty? A systematic review and meta-analysis. Reg Anesth Pain Med. 2021 Aug;46(8):713-721. doi: 10.1136/rapm-2021-102705. Epub 2021 May 14.