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

NCT07024043 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: FMASU MS 173/2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Efficacy of Drugs in Pain Management

Outcome Measures

Primary Outcomes (1)

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

  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

  45 minutes after spinal anaesthesia

Secondary Outcomes (1)

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

  45 minutes after spinal anesthesia

Study Arms (1)

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

EXPERIMENTAL

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 .

Drug: Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries; Procedure: IPACK and multi-modal analgesic regimen

Interventions

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.

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

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 .

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, Egypt, Egypt

Location

Study Officials

• Maisa Essam Abdelhaleem, MBBCH

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 17, 2025
• Study Start: March 3, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Before 1/2026
• Access Criteria: Free

Locations

EG (1)