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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03942133
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 8.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty; Analgesia; Nerve Block	Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal; Procedure: ultrasound-guided long-axis placement of catheter at the middle of the adductor canal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: May 11, 2019
• Actual Primary Completion Date: Dec 8, 2019
• Actual Study Completion Date: Dec 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: entrance placement of adductor canal catheter	Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal; 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
Experimental: middle point placement of adductor canal catheter	Procedure: ultrasound-guided long-axis placement of catheter at the middle of the adductor canal; 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

Outcome Measures

Primary Outcome Measures

1. cumulative sulfentanil consumption at 24 hours after surgery [24 hours after surgery]

Secondary Outcome Measures

1. the strength of quadriceps femoris [0,2,4,8,24,48 hours postoperatively]

   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)

2. The pain scores at rest determined by the numeric rating scale (NRS, 0-10) [at 0,2,4,8,24,48 hours postoperatively]

   11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).

3. 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]

   11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).

4. incidence of postoperative nausea and vomiting (PONV) [within 48 hours after surgery]

5. Patient satisfaction with anesthesia [within 5th day after surgery]

   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)

6. complications [within 3days after surgery]

   Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.

7. cumulative sulfentanil consumption at other time points after surgery [2,4,8,48 hours postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cui Xulei, Attending physician, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03942133
• Other Study ID Numbers: CXL1
• First Posted: May 8, 2019
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cui Xulei, Attending physician, Peking Union Medical College Hospital: adductor canal block
• Additional relevant MeSH terms: Agnosia

Study Results

No Results Posted as of Jan 2, 2020