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Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement

Primary Purpose

Total Knee Arthroplasty, Analgesia, Nerve Block

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal
ultrasound-guided long-axis placement of catheter at the middle of the adductor canal
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Total Knee Arthroplasty focused on measuring adductor canal block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years
  • Knee-arthroscopy
  • Written consent
  • ASA I-III
  • BMI 19-35

Exclusion Criteria:

  • Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
  • coagulopathy or on anticoagulant medication
  • Allergic reactions toward drugs used in the trial
  • History of substance abuse
  • Infection at injection site
  • Can not be mobilised to 5 meters of walk pre-surgery

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

entrance placement of adductor canal catheter

middle point placement of adductor canal catheter

Arm Description

Outcomes

Primary Outcome Measures

cumulative sulfentanil consumption at 24 hours after surgery

Secondary Outcome Measures

the strength of quadriceps femoris
Quadriceps strength was assessed on a 0-5 scale as per the Medical Research Council Scale quadriceps motor strength(0 = no voluntary contraction possible, 1 = muscle flicker, but no movement of limb, 2 = active movement only with gravity eliminated, 3 = movement against gravity but without resistance, 4 = movement possible against some resistance and 5 = normal motor strength against resistance)
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
The pain scores on adduction of the keen determined by the numeric rating scale (NRS, 0-10)
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
incidence of postoperative nausea and vomiting (PONV)
Patient satisfaction with anesthesia
Patient satisfaction with anesthesia was assessed using a 5-point scale (5, very satisfied; 4, satisfied; 3, neither satisfied nor dissatisfied; 2, dissatisfied; 1, very dissatisfied)
complications
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
cumulative sulfentanil consumption at other time points after surgery

Full Information

First Posted
May 6, 2019
Last Updated
December 29, 2019
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03942133
Brief Title
Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
Official Title
Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Block at the Entrance and Middle of the Canal
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2019 (Actual)
Primary Completion Date
December 8, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study compares the tow technique of continues adductor canal block for total knee replacement surgery. Half participants will receive catheterization at the entrance of the adductor canal, while the other half will receive catheterization at the middle point of the adductor canal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Analgesia, Nerve Block
Keywords
adductor canal block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
entrance placement of adductor canal catheter
Arm Type
Experimental
Arm Title
middle point placement of adductor canal catheter
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal
Intervention Description
Ultrasound probe is placed at the entrance of the adductor canal in short axis ，insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the entrance of the canal
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided long-axis placement of catheter at the middle of the adductor canal
Intervention Description
Ultrasound probe is placed at the middle of the adductor canal in long axis with the caphelad end of the probe aligned with the entrance of the canal. insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the middle of the canal
Primary Outcome Measure Information:
Title
cumulative sulfentanil consumption at 24 hours after surgery
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
the strength of quadriceps femoris
Description
Quadriceps strength was assessed on a 0-5 scale as per the Medical Research Council Scale quadriceps motor strength(0 = no voluntary contraction possible, 1 = muscle flicker, but no movement of limb, 2 = active movement only with gravity eliminated, 3 = movement against gravity but without resistance, 4 = movement possible against some resistance and 5 = normal motor strength against resistance)
Time Frame
0,2,4,8,24,48 hours postoperatively
Title
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Description
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
Time Frame
at 0,2,4,8,24,48 hours postoperatively
Title
The pain scores on adduction of the keen determined by the numeric rating scale (NRS, 0-10)
Description
11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).
Time Frame
at 0,2,4,8,24,48 hours postoperatively
Title
incidence of postoperative nausea and vomiting (PONV)
Time Frame
within 48 hours after surgery
Title
Patient satisfaction with anesthesia
Description
Patient satisfaction with anesthesia was assessed using a 5-point scale (5, very satisfied; 4, satisfied; 3, neither satisfied nor dissatisfied; 2, dissatisfied; 1, very dissatisfied)
Time Frame
within 5th day after surgery
Title
complications
Description
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
Time Frame
within 3days after surgery
Title
cumulative sulfentanil consumption at other time points after surgery
Time Frame
2,4,8,48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years Knee-arthroscopy Written consent ASA I-III BMI 19-35 Exclusion Criteria: Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder). coagulopathy or on anticoagulant medication Allergic reactions toward drugs used in the trial History of substance abuse Infection at injection site Can not be mobilised to 5 meters of walk pre-surgery
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33036554
Citation
Fei Y, Cui X, Chen S, Peng H, Feng B, Qian W, Lin J, Weng X, Huang Y. Continuous block at the proximal end of the adductor canal provides better analgesia compared to that at the middle of the canal after total knee arthroplasty: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2020 Oct 9;20(1):260. doi: 10.1186/s12871-020-01165-w.
Results Reference
derived

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Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement

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