Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04968392
Collaborator
(none)
60
1
2
14
4.3

Study Details

Study Description

Brief Summary

Total knee arthroplasty surgery is associated with severe postoperative pain and adequate pain management is necessary for early postoperative mobilization and rehabilitation. Although good postoperative pain control may be achieved by continuous epidural anesthesia or femoral nerve block, both methods have adverse effects such as muscle weakness, which may delay postoperative mobilization.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

The adductor canal block (ACB) is a relatively new block providing analgesia for knee surgery, which not only blocks the largest sensory branch of the femoral nerve but also results in less reduction of quadriceps muscle strength, compared with the femoral nerve block (FNB) in adult patients.

Randomized controlled trials have revealed that ACB provides at least equal analgesia as FNB, preserves quadriceps muscle strength better than FNB, and thus allowing for functional recovery within the first 24-hour post-TKA. However, one important limitation of single-shot peripheral nerve block is the short duration of analgesia. Because the average duration of severe pain after TKA takes 2-3 days, a continuous ACB via catheter would seem to be a good choice. Unfortunately, perineural catheters may be technically difficult to insert, are prone to premature dislodgement, and may increase infection risk. There also were some case reports of local anesthetic-induced myotoxicity after continuous ACB.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Analgesic Efficacy of Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty: a Randomized Clinical Trial
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: L group

20 mL of 0.25% levobupivacaine plus 1 mL normal saline

Drug: Levobupivacaine
20 mL of 0.25% levobupivacaine plus 1 mL normal saline

Experimental: LD group

20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine

Drug: Dexmedetomidine Hydrochloride
20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine

Outcome Measures

Primary Outcome Measures

  1. the first analgesia rescue call. [24 hours postoperative]

    time to the first analgesic request.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA physical status I or II

  • undergoing elective primary total knee arthroplasty surgery under spinal anesthesia.

Exclusion Criteria:
  • Patients with a known history of significant hepatic,

  • renal, heart disease, autoimmune disease,

  • any known convulsive disorder, any psychiatric disorders, chronic pain,

  • pregnant females, regular use analgesics, anti-depressants, or opioids in the previous 2 months, revision surgery, morbid obesity, allergy to local anesthetics or morphine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut governorate Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ghada Mohammed AboelFadl, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04968392
Other Study ID Numbers:
  • 17300626
First Posted:
Jul 20, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
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 Ghada Mohammed AboelFadl, Principal investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021