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

November 14, 2020 updated by: Amal Ibrahim Mubarak

Comparative Study Between Dexamethasone, and Dexmedetomidine as Additives to Bupivacaine in Ultrasound Guided Adductor Canal Block in Knee Arthroscopy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. A trans-arterial landmark-based distal approach to the saphenous nerve block has been shown to reduce pain significantly by providing sensory block to the tissues around the medial meniscus. The saphenous nerve, a terminal branch of the femoral nerve, provides cutaneous sensation to the peripatellar region, and the medial aspect of the lower extremity below the knee, as well as to the articular branches to the medial aspect of the knee joint. The saphenous nerve separates from the femoral nerve in the proximal third of the thigh, courses through the adductor canal with the nerve to the vastus medialis, and emerges from the adductor hiatus to divide into the infrapatellar branch and the sartorial branch. Traditionally, saphenous nerve blocks have been performed as an anatomical landmark-based technique with marginal rates of success, as low as 33%. With ultrasound guidance, the feasibility of effective saphenous nerve block at the adductor canal has been shown tp increase. The adductor canal block may provide superior analgesia over traditional distal saphenous nerve blocks for surgical procedures of the knee because this block includes the saphenous nerve, the nerve to the vastus medialis, and potentially the articular contribution of the obturator nerve to the knee joint. Our primary hypothesis was that performing an adductor canal block as part of a multimodal analgesic regimen would result in improved analgesia immediately following arthroscopic medial meniscectomy. Dexamethasone improves the quality and duration of peripheral nerve block when used as an adjuvant to local anesthetic. Possible mechanisms include: Dexamethasone (as a corticosteroid) was reported to attenuate C-fiber responses. More recent publications indicate that 8 mg dexamethasone added to perineural local anesthetic injections augment the duration of peripheral nerve block analgesia. Dexmedetomidine is a useful sedative agent with analgesic properties, hemodynamic stability and ability to recover respiratory function in mechanically ventilated patients facilitating early weaning. Besides being a new modality of sedation and analgesia in ICU patient management, it has been studied in several other perioperative settings.

researchers suggested that dexmedetomidine likely affects the Aδ and unmyelinated C fibers differently from motor neurons. This phenomenon has been observed before in the setting of neuraxial blockade; however, the exact mechanism of action remains speculative and has been addressed elsewhere. Rationale for using Adjuvants in Regional anesthesia:- Regional anesthesia researchers have been exploring the strategies to prolong the duration of PNB "Peripheral Nerve Blockade" analgesia in patients undergoing ambulatory procedures. Although ambulatory catheters are an effective option, their practical utility is governed by a stringent patient selection criteria. Liposomal bupivacaine is another effective alternative, but its use is limited by price, availability, lack of FDA approval, and the similar prolongation of both sensory and motor blockade duration it produces. Adjuvants constitute another option, and numerous local anesthesia additives, have been explored in search of the ideal adjunct that satisfies the criteria of effectively prolonging the duration of analgesia and not being associated with a significant risk of neurotoxicity. Among these adjuncts, dexamethasone has seemed most promising, because researchers have demonstrated its efficacy when administered intravenously. However, dexmedetomidine as a local anesthetic adjunct may ultimately prove superior to dexamethasone in terms of its differential prolongation of sensory-motor blockade.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Adult patients of aged < 18 years old ASA "American Society of Anaesthesia" physical status I or II under-going any unilateral knee arthroscopy. Exclusion Criteria: -

  1. patient refusal.
  2. Pregnancy or breastfeeding
  3. Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
  4. Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dexamethasone, combined with bupivacaine for adductor canal block

All patients will receive spinal anesthesia with 2.5 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 4 mg dexamethasone.
Procedure: Spinal anaesthesia
spinal anesthesia shall be conducted with 2.5 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position.
Procedure: ultrasound-guided Adductor Canal Block + dexamethasone
Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. A high-frequency linear ultrasound transducer was placed transverse to the longitudinal axis of the extremity at the midthigh level at a distance approximately halfway between the iliac spine and the patella. The femoral artery was identified underneath the sartorius muscle with the vein just underneath the artery. At this position, the saphenous nerve was placed lateral to the artery in the adductor canal (Fig. 1). A 10 cm Tuohy canula 18G "Gauge" (Braun Medical, Melsungen, Germany) was inserted, in plane, from the lateral side of the transducer, through the sartorius muscle with the tip placed lateral to the artery. then, a 20-ml mixture of 0.25% bupivacaine, and 4 mg dexamethasone will be injected.
ACTIVE_COMPARATOR: Dexmedetomedine, combined with bupivacaine for adductor canal block

All patients will receive spinal anesthesia with 2.5 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.
Procedure: Spinal anaesthesia
spinal anesthesia shall be conducted with 2.5 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position.
Procedure: ultrasound-guided Adductor Canal Block + dexmedetomedine
Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. A high-frequency linear ultrasound transducer was placed transverse to the longitudinal axis of the extremity at the midthigh level at a distance approximately halfway between the iliac spine and the patella. The femoral artery was identified underneath the sartorius muscle with the vein just underneath the artery. At this position, the saphenous nerve was placed lateral to the artery in the adductor canal (Fig. 1). A 10 cm Tuohy canula 18G "Gauge" (Braun Medical, Melsungen, Germany) was inserted, in plane, from the lateral side of the transducer, through the sartorius muscle with the tip placed lateral to the artery.then, a 20-ml mixture of 0.25% bupivacaine, and 0.5 Mg/kg dexmedetomidine will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia (resting visual analogue score) .
Time Frame: 24 hours
the time passed from block to the patient's first analgesic request
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amal Ibrahim Mubarak

Investigators

  • Study Chair: Hamdy A Yousef, professor, Professor of Anesthesia and Intensive care unit, faculty of medicine, Assiut University
  • Study Director: Rasha A Ali, Lecturer, Lecturer of Anesthesia and Intensive care unit, faculty of medicine, Assiut University
  • Principal Investigator: Amal I Mubarak, Resident, Medical Resident at Anesthesia and ICU department, faculty of medicine, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (ACTUAL)

November 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 14, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • knee regional anaesthesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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