NCT03942133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

May 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

7 months

First QC Date

May 6, 2019

Last Update Submit

December 29, 2019

Conditions

Total Knee ArthroplastyAnalgesiaNerve Block

Keywords

adductor canal block

Outcome Measures

Primary Outcomes (1)

  • cumulative sulfentanil consumption at 24 hours after surgery

    24 hours after surgery

Secondary Outcomes (7)

  • the strength of quadriceps femoris

    0,2,4,8,24,48 hours postoperatively

  • The pain scores at rest determined by the numeric rating scale (NRS, 0-10)

    at 0,2,4,8,24,48 hours postoperatively

  • The pain scores on adduction of the keen determined by the numeric rating scale (NRS, 0-10)

    at 0,2,4,8,24,48 hours postoperatively

  • incidence of postoperative nausea and vomiting (PONV)

    within 48 hours after surgery

  • Patient satisfaction with anesthesia

    within 5th day after surgery

  • +2 more secondary outcomes

Study Arms (2)

entrance placement of adductor canal catheter

EXPERIMENTAL
Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal

middle point placement of adductor canal catheter

EXPERIMENTAL
Procedure: ultrasound-guided long-axis placement of catheter at the middle of the adductor canal

Interventions

ultrasound-guided short-axis placement of catheter at the entrance of the adductor canalPROCEDURE

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

entrance placement of adductor canal catheter
ultrasound-guided long-axis placement of catheter at the middle of the adductor canalPROCEDURE

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

middle point placement of adductor canal catheter

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

  • 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.

    PMID: 33036554DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 8, 2019

Study Start

May 11, 2019

Primary Completion

December 8, 2019

Study Completion

December 16, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)