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

July 26, 2024 updated by: Rasha Hamed

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 and a control group for pain-free knee arthroscopic surgeries.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

135

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 Locations

  • Egypt
      • Assiut, Egypt
        • Rasha Hamed

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

Description

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 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 Assignment
  • Masking: Triple

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 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.
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 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.
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.
Active Comparator: control group

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
Procedure: ultrasound-guided Adductor Canal Block
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Visual Analogue Scale score
Time Frame: month 1 postoperative
a scale of 11 points. 0 = no pain, 10=worst pain
month 1 postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Rasha Hamed

Investigators

  • Study Chair: Hamdy A Yousef, MD, Professor of Anesthesia and Intensive care unit, faculty of medicine, Assiut University
  • Study Director: yara A yousef, Lecturer, Lecturer of Anesthesia and Intensive care unit, faculty of medicine, Assiut University
  • Principal Investigator: rasha hamed, MD, aisstant professor of anesthesia and ICU

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 (Actual)

January 1, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

December 30, 2023

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)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

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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