Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty (GenTKR)

NCT04024319 | Completed

• 1 other identifier: HCB/2018/0463
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Knee Osteoarthritis affects one third of the population over 65 years old. Total knee arthroplasty (TKA) has become one of the most frequent surgical procedures in the world. During the last years it went from being a long hospital stay surgery to a fast track procedure. Currently models employ high volume local infiltration techniques (LIA). The genicular nerve block (GNB) appears as alternative in this patients. The objective of this study is to evaluate the analgesic results of genicular nerve block after TKA in a small cohort of patients. 35 patients scheduled for TKA underwent to GNB were included. Pain measurement.

Conditions

Pain, Postoperative; Knee Pain Chronic

Keywords

Total Knee Replacement; Genicular nerves block; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Maximum Pain score in first day after surgery

  Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.

  48 hours

Study Arms (2)

Genicular Nerve Block

GNB will be performed on this group of patients undergoing TKR. The patient will be positioned in the supine position, with the extremity to operate slightly in external rotation. The anesthesiologist will be located ipsilateral to the knee to intervene; asepsis will be performed with 70% chlorhexidine, sterile gloves will be used and the ultrasound probe will be protected with a sterile cover. The ultrasound transducer will be placed in a long axis of the knee in the corresponding area to block according to anatomical repairs. 4 ml of 0,2% ropivacaine was administered in each GN.

Procedure: Genicular Nerve Block

Local Infiltration Analgesia

Retrospectively, the data of the patients belonging to the control group (LIA) were collected through the electronic file in the SAPP program of the internal network of the Barcelona Clinic Hospital in chronological order until completing 35 cases. To include them in the control group, the patients had to meet the same criteria as those belonging to the intervention group (GNB), therefore, the surgery should have been performed under spinal anesthesia and subsequently followed with an oral analgesia schedule meeting criteria of fast track hospitalization. The same data were obtained as in the GNBG, demographic data (age, sex, weight, height, hematocrit, hemoglobin, ASA), duration of the surgery and ischemia time, PACU VAS, AM VAS, PM VAS and finally some data of the post-operative period (hematocrit, hemoglobin, transfusion, hospital stay)

Interventions

Genicular Nerve Block PROCEDURE

4 ml of local anesthetic were administered in 5 genicular nerves. A total volume of 20 ml were administered in GNB group.

Genicular Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing TKR in Hospital Clinic

You may qualify if:

• Subjects undergoing TKR
• Acceptance to participate
• ASA physical status II-III
• Age \> 18 years

You may not qualify if:

• Refusal to participate in the study
• Allergy to local anesthetics
• History of substance abuse

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, 0836, Spain

Location

Related Publications (1)

• Pietrantoni P, Cunat T, Nuevo-Gayoso M, Martin N, Tio M, Basora M, Sastre S, Sala-Blanch X. Ultrasound-guided genicular nerves block: an analgesic alternative to local infiltration analgesia for total knee arthroplasty: A noninferiority, matched cohort study. Eur J Anaesthesiol. 2021 Aug 1;38(Suppl 2):S130-S137. doi: 10.1097/EJA.0000000000001546.

  PMID: 34038916 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• xavier sala-blanch, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 18, 2019
• Study Start: May 28, 2018
• Primary Completion: September 28, 2018
• Study Completion: October 1, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)