Perineural Dexamethasone in the Adductor Canal Block

NCT06079047 | Completed

• 1 other identifier: CE-IMKO- 111/2023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain management in total knee arthroplasty (TKA) surgery is a real challenge for the anesthesiologist. Effective pain control must be provided while preserving the mobility to ensure early rehabilitation. The adductor canal block is an effective way to induce sensory block without motor block. However, the major disadvantage of this block is the duration of sensory block which may be insufficient for postoperative pain management in TKA surgery. Many studies have focused on finding molecules that can prolong sensory block without the need for a perineural catheter and dexamethasone is among the most studied molecules(1, 2). Hence, our study aims to evaluate the added value of perineural dexamethasone in the adductor canal block in TKA surgery. \[

Conditions

Post Operative Pain

Keywords

knee arthroplasty; glucocorticoids; adductor canal block

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  postoperative consumption of morphine

  48 hours

Secondary Outcomes (12)

• NRS at rest

  1 hour, 3 hours, 6 hours, 9 hours,12 hours, 24 hours, 36 hours and 48 hours postoperatively

• NRS on mouvement

  1 hour, 3 hous, 6 hours, 9 hours,12 hours, 24 hours, 36 houes and 48 hours postoperatively

• knee mouvement

  preoperatively, on day 1 and day 7 postoperatively

• walk

  day 1 and day 2 postoperatively

• Patient's satisfaction

  48 hours postoperatively

Study Arms (2)

group Dexamethasone

EXPERIMENTAL

adductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of "dexamethasone" (8 mg)

Procedure: group Dexamethasone

group Controle

ACTIVE COMPARATOR

adductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of 0.9% saline solution

Procedure: group Controle

Interventions

group Dexamethasone PROCEDURE

Adductor canal block with dexamethasone

group Dexamethasone

group Controle PROCEDURE

Adductor canal block with saline solution

group Controle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for unilateral TKA
• Surgery under spinal anesthesia
• ASA class I, II, and III patients

You may not qualify if:

• Patient refusal to participate in the study
• Contraindication to regional anesthesia
• Allergies to the products used
• Bilateral TKA
• Revision TKA
• TKA in the context of inflammatory or post-traumatic disease
• BMI \> 45
• Poorly controlled diabetic patients with HbA1c \> 8%
• Patients on corticosteroid therapy or who have received an intra-articular injection of corticosteroids

Sponsors & Collaborators

• Olfa kaabachi, MD: lead

Study Sites (1)

KAABACHI

Tunis, La Mannouba, 2010, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: October 12, 2023
• Study Start: December 15, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)