NCT06486246

Brief Summary

Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Therefore, in recent years, the adductor canal block (ACB) has been used for postoperative analgesia with variable results. Genicular nerve block (GNB) has been used for pain management in patients with knee osteoarthritis and recently in knee arthroplasty surgery with results similar to the local anesthetic infiltration techniques by the surgeon (LIA). Considering their good results in these patients in addition to being a 100% sensitive block without risk of motor involvement. The investigators proposed this experimental study to evaluate tha analgesic efficacy of the genicular nerve block (GNB) compared with the adductor canal block (ACB) for the Anterior cruciate ligament (ACL) repair surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

May 2, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain assessed by NRS at PACU

    Numerical raiting score (NRS) 0-10 (0= No pain; 10=maximum pain)

    up to 6 hours postoperative

  • Opioid consumption at PACU

    Metadone consumption in mg.

    up to 6 hours postoperative

Secondary Outcomes (2)

  • Pain score at home

    up to 24 hours

  • Quality of rest

    First night

Study Arms (2)

Adductor canal block

EXPERIMENTAL

Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist prior the surgery, after inducction of general anesthesia.

Procedure: Adductor canal block

Genicular nerve block

EXPERIMENTAL

Injection of local anaesthetics under ultrasound guidance in the genicular nerves ( Superomedial genicular nerve, superolateral genicular nerve and inferomedial genicular nerve) by the anaesthesiologist prior the surgery, after inducction of general anesthesia.

Procedure: Adductor canal block

Interventions

Injection of the local anesthetic prior to the surgery, either in the the adductor canal or in the genicular nerves by the anesthesiologist under ultrasound guidance.

Also known as: Genicular nerve block
Adductor canal blockGenicular nerve block

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

You may not qualify if:

  • peripheral neuropathy
  • pre-existing femoral neuropathy
  • diabetes mellitus
  • alcoholism
  • drug addiction
  • cancer with chemotherapy
  • chronic pain state
  • Negative of the patient to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 0836, Spain

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesPain, Postoperative

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: UNIcenter Non-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 2, 2024

First Posted

July 3, 2024

Study Start

June 26, 2024

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations