NCT04443634

Brief Summary

Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries potential benefits that encourage anesthesiologists to do it. It has a motor sparing property. Injection of local anesthetics in this lengthy canal that contains a variable amount of connective or fibrous tissue might lead to a patchy distribution of local anesthetics. Thus, the possibility of incomplete block of the saphenous nerve (most important nerve in knee innervations) cannot be excluded.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

June 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 18, 2020

Last Update Submit

June 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The total dose of morphine consumption in the first 24 hours postoperatively.

    The total amount of morphine consumption in the first 24 hours postoperatively.

    24 hours postoperative

Secondary Outcomes (4)

  • Total dose of intraoperative fentanyle adminstration

    2 hours intraoperatively

  • Numeric Pain Rating Scale

    24 hours postoperative

  • Failure rate of the block

    24 hours

  • Block related complications

    1 mounth

Study Arms (3)

Adductor 20

EXPERIMENTAL

Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine

Procedure: Ultrasound Guided Adductor Canal BlockProcedure: General anesthesiaDrug: Bupivacaine 20 ml

Adductor 30

EXPERIMENTAL

Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine

Procedure: Ultrasound Guided Adductor Canal BlockProcedure: General anesthesiaDrug: Bupivacaine 30ml

Adductor /Saphenous

EXPERIMENTAL

Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.

Procedure: Ultrasound Guided Adductor Canal BlockProcedure: Ultrasound Guided Saphenous Nerve BlockProcedure: General anesthesiaDrug: Bupivacaine 20 mlDrug: Bupivacaine 10ml

Interventions

It will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe. Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery. From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle. With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal. the volume of local anesthetic will be selected according to the studied group

Adductor /SaphenousAdductor 20Adductor 30

It will be performed at the intermuscular plane between the sartorius and the vasus medialis muscles at the lower third of the thigh. The US probe will be positioned on the front of the lower part of the thigh immediately above the patella to see both the patella (hyperechoic curved line) and vastus medialis infront of it (closer to skin). The probe is then moved medially over the vastus medialis till we see the end of the muscle and we see an intermuscular plane between it and Sartorius muscle. A 20 guage spinal needle will be then passed in an in plane direction within the substance of vastus medialis muscle and then pass within the vastus medialis until it faces the intermuscular plane between VM muscle and Sartorius. Once the needle tip is located in close proximity to the target structures, gentle aspiration will be performed followed by 20 ml local anesthetic will be injected.

Adductor /Saphenous

General anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%. Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control. Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization.

Adductor /SaphenousAdductor 20Adductor 30

20ml bupivacaine 0.5%

Adductor /SaphenousAdductor 20

30ml bupivacaine 0.5%

Adductor 30

10ml bupivacaine 0.5%

Adductor /Saphenous

Eligibility Criteria

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

You may qualify if:

  • Scheduled for knee orthopedic ( ACL repair)
  • Physical status ASA I, II.
  • Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

You may not qualify if:

  • Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Infection of the skin at the site of needle puncture area.
  • Patient refusal.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Pregnancy.
  • Patient with surgery duration more than two hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department

Cairo, Egypt

RECRUITING

Related Publications (4)

  • Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.

    PMID: 20889937BACKGROUND
  • Ilfeld BM, Moeller LK, Mariano ER, Loland VJ, Stevens-Lapsley JE, Fleisher AS, Girard PJ, Donohue MC, Ferguson EJ, Ball ST. Continuous peripheral nerve blocks: is local anesthetic dose the only factor, or do concentration and volume influence infusion effects as well? Anesthesiology. 2010 Feb;112(2):347-54. doi: 10.1097/ALN.0b013e3181ca4e5d.

    PMID: 20098137BACKGROUND
  • Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.

    PMID: 25386752BACKGROUND
  • Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

    PMID: 19916251BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, GeneralBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Bassant abdelhamid

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bassant abdelhamid, M.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 23, 2020

Study Start

June 25, 2020

Primary Completion

September 25, 2020

Study Completion

October 1, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations