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

NCT06145165 | Unknown Phase 4

• 1 other identifier: KY20230829-05
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liposomal Bupivacaine; Postoperative Recovery; Unilateral Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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 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.

• 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.

• 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.

• 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.

Study Arms (3)

RP group:Nerve block with ropivacaine and intravenous analgesia group

PLACEBO COMPARATOR

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

Other: Nerve block with ropivacaine and intravenous analgesia

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

EXPERIMENTAL

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

Combination Product: Nerve block with liposomal bupivacaine and intravenous analgesia

control group：Intravenous analgesia group

PLACEBO COMPARATOR

General anesthesia was induced directly

Other: Intravenous analgesia

Interventions

Nerve block with ropivacaine and intravenous analgesia OTHER

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.

RP group:Nerve block with ropivacaine and intravenous analgesia group

Nerve block with liposomal bupivacaine and intravenous analgesia COMBINATION_PRODUCT

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.

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

Intravenous analgesia OTHER

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.

control group：Intravenous analgesia group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 30094112 BACKGROUND

• 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.

  PMID: 19301724 BACKGROUND

• 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.

  PMID: 27400891 BACKGROUND

• 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.

  PMID: 29921393 BACKGROUND

• 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.

  PMID: 27871547 BACKGROUND

• 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.

  PMID: 34653576 BACKGROUND

• 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.

  PMID: 36042669 BACKGROUND

• 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.

  PMID: 33990436 BACKGROUND

MeSH Terms

Interventions

Nerve Block; Ropivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Liu Han

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Liu Han

CONTACT

18951670163; han_cold.student@sina.com

Ying Zhang

CONTACT

15380998716; 1070434273@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 24, 2023
• Study Start: December 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 23, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)