Comparison of Two Techniques of Locoregional Analgesia in Total Knee Prosthesis Surgery : Block to the Adductor Channel Versus Peri-articular Local Infiltrations

Comparison of Two Techniques of Locoregional Analgesia in Total Knee Prosthesis Surgery : Block to the Adductor Channel Versus Peri-articular Local Infiltrations

Sponsors

Lead Sponsor: Hospices Civils de Lyon

Source Hospices Civils de Lyon
Brief Summary

The post-operative pain generated by prosthetic knee replacement surgery is known to be moderate to severe during two or three days following surgery.

The most popular analgesic technique after prosthetic knee replacement surgery remains the femoral block (FB), whether in single injection or continuous infusion. In major knee surgery, FBs provide better analgesia compared to systemic morphine and FBs provide the same analgesia that obtained with epidural analgesia but with fewer associated adverse effects.

Although FBs provide excellent post-operative analgesia after total knee prosthesis, they also provide a significant quadricepsia weakness that increases the risk of severe falls and complications, and hinders the rapid rehabilitation process. For these reasons, alternative analgesic techniques have emerged in recent years.

To avoid the quadricipital motor block generated by FBs, some authors proposed the administration of local anesthetics in the adductor channel, also known as the Hunter channel, in order to produce a pure sensory block. With the development of ultrasound, the adductor channel is easily visualized in the middle of the thigh. This allows the adductor channel block (ACB) to be realized with a high success rate. ACB appears to decrease postoperative pain and morphine consumption. It also significantly improves the ability of patients to walk around after Total Knee Arthroplasty (TKA) surgery.

With the same goal of quadricipital savings, the use of the analgesic technique by periarticular infiltration of local anesthetics (ILA) has spread in recent years, due to the fact that an analgesic technique of simple realization and without apparent danger, and this despite limited evidence of its effectiveness.

The Croix-Rousse Hospital is a university hospital in Lyon with a highly developed orthopedic surgery center, producing approximately 550 TKA per year. During the year 2016, approximately half were benefited from post-operative analgesia management by ACB, and the other half by the implementation of the ILA.

To date few studies have been interested in comparing these two analgesic techniques in knee prosthesis surgery.

Overall Status Recruiting
Start Date February 7, 2018
Completion Date January 2020
Primary Completion Date January 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
the cumulative consumption of MORPHINE during the first 48 hours following the surgical incision
Secondary Outcome
Measure Time Frame
Pain at rest Resting pain will be measured every 4 hours in the first 24 hours, then every 8 hours between 24 and 72 hours
pain in movement at day 3
quality of the analgesia offered by the ACB within 48 hours after the injection to the adductor channel
quality of the analgesia offered by the ILA within 48 hours after the end of surgery
quality of the analgesia within 48 hours after the surgical incision time
Functional capabilities and rehabilitation at day 3
Duration of hospitalization at day 3
Patient satisfaction at day 3
Secondary complications due to adductor channel block Day 0 : At the time of the ACB in the pre-induction room
Complications secondary to analgesic medications and surgery at day 3
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: locoregional analgesia by a block on the adductor channel

Description: The block at the adductor channel will be realized under echo guidance, before the spinal anesthesia, by puncture at the upper 1/3 of the thigh. It will be used echogenic needle adapted to the morphotype of each patient, of varying length from 50mm to 100mm. A single injection of 20mL of ROPIVACAINE 2mg / ml, the efficacy of which should be checked before spinal anesthesia is performed by a cold test. Knee analgesia will be supplemented by per-operative infiltration of 50mL of ROPIVACAINE 2mg / ml at the posterior capsule, once the surfaces joints prepared to accommodate the prosthesis and by two placebo infiltrations of 50mL each of physiological saline in the medial and lateral ligaments and in the edges of the incision.

Arm Group Label: locoregional analgesia by a block on the adductor channel

Intervention Type: Drug

Intervention Name: locoregional analgesia by periarticular local infiltrations

Description: A placebo injection to the adductor channel of 20 mL of physiological serum will be performed in the pre-induction room before surgery, according to the same procedures as the patients of the ACB group. During the surgical procedure, patients in the ILA group will receive a total dose of 300mg of ROPIVACAINE 2mg / ml in the form of 3 periarticular injections. The first injection of 50mL of ROPIVACAINE 2mg / ml will be made once the articular surfaces are prepared to receive the prosthesis, at the level of the posterior capsule. The second injection of 50mL of ROPIVACAINE 2mg / ml will be performed once the total knee prosthesis is installed, in the medial and lateral ligaments. Finally, the last injection will also include 50mL of ROPIVACAINE 2mg / ml and will be made in the edges of the incision at the time of closure.

Arm Group Label: locoregional analgesia by periarticular local infiltrations

Eligibility

Criteria:

Inclusion Criteria:

- Major patients (≥18 years),

- Having an American Society of Anesthesiology score (ASA) I to III

- To benefit from first and unilateral prosthetic replacement surgery of knee under spinal anesthesia,

- Having social security scheme,

- Having received informed information and having signed informed consent

Exclusion Criteria:

- Pregnant women (diagnosis of interrogation),

- Breastfeeding women

- Patients under tutorship or curatorship,

- Persons who can not receive sufficient information because of disturbances of superior functions or because of insufficient command of the French language according to the judgment of the investigator,

- A history of chronic neuropathic pain in the leg to be operated on,

- Patients who have undergone prior surgery on the knee to perform surgery,

- Contra-indication to loco-regional anesthesia: known allergy to local anesthetics,

- Contra-indication to the use of ROPIVACAINE: known hypersensitivity to the active substance or other amide-linked local anesthetics, hypovolemia

- A morbid obesity (Body Mass Index (BMI)> 40),

- Severe renal insufficiency (Glomerular Filtration Rate (GFR) <30mL / min),

- Severe hepatic impairment (prothrombin rate PR <50%),

- Heart failure (left ventricular ejection fraction (LVEF)<40%),

- Transplanted patients,

- A history of drug abuse,

- The taking of chronic morphine for 6 months in systematic,

- Any inability to understand visual scale,

- An inability to walk pre-existing,

- Participation in other interventional research, excluding physiological studies and other interventional research that does not interfere with the analysis of the primary endpoint (as determined by the investigator).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Caroline Macabeo Principal Investigator Hospices Civils de Lyon
Overall Contact

Last Name: Caroline Macabeo, MD

Phone: 4 26 10 92 53

Phone Ext.: +33

Email: [email protected]

Location
Facility: Status: Croix Rousse Hospital
Location Countries

France

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: locoregional analgesia by a block on the adductor channel

Type: Experimental

Label: locoregional analgesia by periarticular local infiltrations

Type: Experimental

Acronym SALIA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov