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

September 19, 2024 updated by: Nanjing First Hospital, Nanjing Medical University

A Analgesic Study of Adductor Canal &IPACK Block with Liposomal Bupivacaine in Knee Arthroplasty ：A Randomized，Double-controlled，Parallel-controlled，Single-center Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: RP group:Nerve block with ropivacaine and intravenous analgesia group
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
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.
Experimental: LP group ：Nerve block with liposomal bupivacaine and intravenous analgesia group
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
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.
Placebo Comparator: control group：Intravenous analgesia group
General anesthesia was induced directly
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
Time Frame: 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.
Up to 48 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
The total number of PCIA compressions on the first day,the second day and the third day after surgery.
Time Frame: 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.
The number of effective PCIA compressions on the first day,the second day and the third day after surgery.
Time Frame: 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.
The number of times of remedial analgesia on the first day,the second day and the third day after surgery.
Time Frame: 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.
The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.
Time Frame: 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.
The percentage of subjects who did not use remedial analgesics on the first day,the second day and the third day after surgery.
Time Frame: 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.
Satisfaction score of subjects on the first day,the second day and the third day after surgery.
Time Frame: 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.
Satisfaction score of surgeons on the first day,the second day and the third day after surgery.
Time Frame: 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.
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.
Time Frame: within 72 hours after the first postoperative initiation of drug administration
A smaller PI-AUC72 indicates a longer duration of nerve block.
within 72 hours after the first postoperative initiation of drug administration
15-item Quality of Recovery Rating Scale (QoR-15): 24hours, 48hours and 72hours postoperatively
Time Frame: 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.
at 24 hours, 48 hours and 72 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Liu Han, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20230829-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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