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

NCT ID: NCT07024043

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-09-03

Brief Summary

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

Detailed Description

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 .

Conditions

Efficacy of Drugs in Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac

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 .

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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 .

Interventions

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

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.

Intervention Type: DRUG

IPACK and multi-modal analgesic regimen

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 .

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maisa Essam Abdelhaleem, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

FMASU MS 173/2025

Identifier Type: -

Identifier Source: org_study_id