Comparing Dexamethasone With Dexmedetomidine as Additives to Bupivacaine in Adductor Canal Block for Knee Arthroscopy.

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: ultrasound-guided Adductor Canal Block; Procedure: Spinal anaesthesia; Procedure: ultrasound-guided Adductor Canal Block + dexmedetomedine; Procedure: ultrasound-guided Adductor Canal Block + dexamethasone

• Registration Number: NCT04631822
• Lead Sponsor: Rasha Hamed

Brief Summary

a comparison shall be conducted between dexamethasone accompanied by bupivacaine, on one hand, and dexmedetomedine accompanied by bupivacaine on the other hand and a control group for pain-free knee arthroscopic surgeries.

Detailed Description

Arthroscopic knee surgery can cause significant postoperative pain to the degree that can potentially delay timely discharge from the ambulatory surgical setting. Analgesia after knee surgery can be provided by multiple, non-systemic, non-opioid-based methods, including local anesthetic infiltration, peripheral nerve blockade, neuraxial procedures, and intra-articular injections. The femoral nerve block has been shown to be superior to traditional intra-articular injection of local anesthetics in some knee surgeries, but motor blockade of the quadriceps muscle, with the potential risk for falls, limits the value of femoral blocks for less invasive ambulatory surgery. Orthopedic surgery is increasingly being performed on an ambulatory basis, where perioperative analgesia can improve timely discharge in the outpatient setting.

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-14
• Study First Posted: 2020-11-17
• Study Start: 2021-01-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Adult patients of aged more than 18 years old ASA "American Society of Anaesthesia"
• physical status I or II under-going any unilateral knee arthroscopy.

Exclusion Criteria

• patient refusal.
• Pre-existing pain ; postoperative pain similar to preoperative pain
• Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
• Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	ultrasound-guided Adductor Canal Block	All patients will receive spinal anesthesia with 3 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position. Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. In this arm, patients will receive 20 ml mixture of 0.25% bupivacaine with no additives
Dexmedetomedine, combined with bupivacaine for adductor canal block	ultrasound-guided Adductor Canal Block + dexmedetomedine	All patients will receive spinal anesthesia with 3 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position. Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. In this arm, patients will receive 20 ml mixture of 0.25% bupivacaine and 0.5 Mg/kg dexmedetomidine.
Dexamethasone, combined with bupivacaine for adductor canal block	Spinal anaesthesia	All patients will receive spinal anesthesia with 3 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position. Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. In this arm, patients will receive 20 ml mixture of 0.25% bupivacaine and 8 mg dexamethasone.
Dexamethasone, combined with bupivacaine for adductor canal block	ultrasound-guided Adductor Canal Block + dexamethasone	All patients will receive spinal anesthesia with 3 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position. Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. In this arm, patients will receive 20 ml mixture of 0.25% bupivacaine and 8 mg dexamethasone.
Dexmedetomedine, combined with bupivacaine for adductor canal block	Spinal anaesthesia	All patients will receive spinal anesthesia with 3 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position. Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. In this arm, patients will receive 20 ml mixture of 0.25% bupivacaine and 0.5 Mg/kg dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
Dynamic Visual Analogue Scale score	month 1 postoperative	a scale of 11 points. 0 = no pain, 10=worst pain

Secondary Outcome Measures

Name	Time	Method
24 hours opioid analgesia consumed	24 hours postoperative
month 3 opioid analgesia	month 3 postoperative	amount of oral codeine consumed postoperative
Visual Analogue Scale score	24 hours postoperative	a scale of 11 points. 0 = no pain, 10=worst pain
Dynamic Visual Analogue Scale score	month 3 postoperative	a scale of 11 points. 0 = no pain, 10=worst pain

Trial Locations

Locations (1)

Rasha Hamed; 🇪🇬 Assiut, Egypt