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

Postoperative Recovery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145165
• Other study ID #: KY20230829-05
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Liu Han
• Phone: 18951670163
• Email: han_cold.student[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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~?;

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.

Related Conditions & MeSH terms

• Liposomal Bupivacaine
• Postoperative Recovery
• Unilateral Knee Arthroplasty

Intervention

Other:
• 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.

Combination Product:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Sundarathiti P, Ruananukul N, Channum T, Kitkunasathean C, Mantay A, Thammasakulsiri J, Sodsee W. A comparison of continuous femoral nerve block (CFNB) and continuous epidural infusion (CEI) in postoperative analgesia and knee rehabilitation after total knee arthroplasty (TKA). J Med Assoc Thai. 2009 Mar;92(3):328-34. — View Citation

Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11. — View Citation

Yu YL, Cao DH, Chen B, Yang ZH, You KZ. Continuous femoral nerve block and patient-controlled intravenous postoperative analgesia on Th1/Th2 in patients undergoing total knee arthroplasty. J Biol Regul Homeost Agents. 2018 May-Jun;32(3):641-647. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group	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.	Up to 48 hours postoperative
Secondary	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	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.	at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative
Secondary	The total number of PCIA compressions on the first day,the second day and the third day after surgery.	Fewer total PCIA compressions indicated a longer duration of block.	On the first day,the second day and the third day after surgery.
Secondary	The number of effective PCIA compressions on the first day,the second day and the third day after surgery.	Fewer total effective PCIA compressions indicated a longer duration of block.	On the first day,the second day and the third day after surgery.
Secondary	The number of times of remedial analgesia on the first day,the second day and the third day after surgery.	Fewer times of rescue analgesia indicated a longer duration of analgesia.	On the first day,the second day and the third day after surgery.
Secondary	The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.	Less cumulative use of analgesics indicates a longer duration of block	On the first day,the second day and the third day after surgery.
Secondary	The percentage of subjects who did not use remedial analgesics 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.	On the first day,the second day and the third day after surgery.
Secondary	Satisfaction score of subjects 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.	On the first day,the second day and the third day after surgery.
Secondary	Satisfaction score of surgeons 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.	On the first day,the second day and the third day after surgery.
Secondary	Both the liposomal bupivacaine group and the ropivacaine group were subjected to ACB and iPACK block. PI-AUC72 was observed in the three groups	A smaller PI-AUC72 indicates a longer duration of nerve block.	within 72 hours after the first postoperative initiation of drug administration
Secondary	15-item Quality of Recovery Rating Scale (QoR-15): 24h, 48h and 72h postoperatively	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.	at 24 hours, 48 hours and 72 hours postoperative