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NCT Number: NCT07024043

Dexamethasone Versus Dexmedetomidine in IPACK Block to Reduce Pain Post Arthroscopic Knee Surgeries

The investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in IPACK Block and it's direct effect in decreasing pain post operative following Arthroscopic knee surgeries

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Efficacy of Drugs in Pain Management

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ain Shams University

Cairo, Egypt

About this study

A.Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. B.Intraoperative and postoperative settings: On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg. For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physical status: ASA I,II. Both sexes. BMI<35

Exclusion criteria

  • Refusal of the procedure or participation in the study by the patient. Physical status: ASA III or Above. History of allergy to the study drug. Evidence of local infection at site of injection. Major hepatic, renal, or cardiovascular dysfunction. BMI>35.

Treatment and study plan

Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries

Drug

Blocks will be carried out with the patient supine with the operative leg externally rotated and slightly flexed at the knee or in prone position.with Ultrasound device with a high-frequency (6-13 MHz) linear probe using in plane lateral to medial approach and this will be done by a senior staff anaesthesia physician skilled in ultrasound guided regional anaesthesia.

IPACK and multi-modal analgesic regimen

Procedure

patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .

Primary outcomes

  1. Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries

    Time frame: 45 minutes after spinal anaesthesia

    postoperative analgesic effect will be assessed by the time till first analgesic requirement which is defined as the time (in hours) after finishing of ultrasound guided iPACK block till the patient's requirement for first analgesia postoperative in ward.

    Postoperative pain will be assessed by visual analog scale (VAS) up to 24 h after surgery. Whenever VAS score reached ≥ 4, rescue analgesia will be given in the form of iv injection diclofenac sodium 75 mg. Time to the first dose of diclofenac sodium postoperatively will be recorded

Secondary outcomes

  1. Effect Of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia following Arthroscopic Knee Surgeries

    Time frame: 45 minutes after spinal anesthesia

    Total analgesics consumption (in mg.) over 24-hour period post-operative.

    Incidence of adverse effects such as:

    Hematoma, hypotension (considered as significant hypotension when blood pressure decrease by 20% relative to baseline), bradycardia (considered as significant bradycardia when heart rate decrease by 20% relative to baseline), nausea and/or vomiting, local anesthetic toxicity, post operative paresthesia, sedation (assessed by Ramsay sedation score) and hypoxemia (Spao2<90%) will be recorded in both groups and will be properly managed by fluid reuscitation, oxygen support, vasopressor and proton pump inhibitors.

    Post-operative ambulation enhancement in the form of: time of start of ambulation (in hours) starting from end of surgery- walking- climbing stairs (according to the New Knee Society Knee Scoring System)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia Following Arthroscopic Knee Surgeries

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.