Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries

NCT06759116 | Recruiting

• 1 other identifier: 940
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be undertaken to compare the analgesic effects of of fentanyl versus dexmedetomidine as adjuvant to bupivacaine in combined IPACK and ACB for pain management after total knee arthroplasty.

Conditions

Analgesia, Postoperative

Keywords

fentanyl; dexamedetomidine; analgesia; IPACK and adductor canal block; knee surgeries

Outcome Measures

Primary Outcomes (2)

• ● The total amount of rescue analgesic consumption (tramadol)

  ● The total amount of rescue analgesic consumption (tramadol) postoperatively in each group

  For 48 hrs

• Pain intensity by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points

  NRS is 10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain)

  0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs

Secondary Outcomes (4)

• The time to first request of rescue analgesia (tramadol)

  24 hours postoperative

• The length of hospital stays

  For 48-72 hrs

• The incidence of adverse events

  For 48 hrs

• patient's satisfaction

  For 48 hrs

Study Arms (3)

Control group (group C)

ACTIVE COMPARATOR

The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline)

Procedure: Control group

Fentanyl group (group F)

ACTIVE COMPARATOR

The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl)

Procedure: Fentanyl group

Dexmedetomidine group (group D)

ACTIVE COMPARATOR

The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). )

Procedure: Dexmedetomidine group

Interventions

Control group PROCEDURE

The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline)

Control group (group C)

Fentanyl group PROCEDURE

The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl)

Fentanyl group (group F)

Dexmedetomidine group PROCEDURE

The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). )

Dexmedetomidine group (group D)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient acceptance 2. Cooperative patients 3. Age: ≥21 and 85\< years' old 4. Sex: both sexes (males or females). 5. Physical status: ASA Ι \& II\& Ш. 6. Body Mass Index (BMI): ≤ 35 kg/m2. 7. Type of operation: elective unilateral knee surgeries (TKA, ACL, knee arthroscopy)

You may not qualify if:

• Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site) 2. Patients with known history of allergy to the study drugs (bupivacaine, dexmedetomidine and fentanyl).
• \. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.
• Chronic opioid use (more than 3 months or daily oral morphine \> 5 mg /day for 1 month)

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of human medicine, Zagazig university hospitals

El Sharkia, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Dina Sadek Salem, MD

CONTACT

01099333513; sherifelagamy@yahoo.com

Sherif Mowafy, MD

CONTACT

01003523374; sherifmowafy2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: anesthetist not sharing in the study will assess patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Analgesic Effect of Fentanyl versus Dexmedetomidine as Adjuvants to Bupivacaine in combined IPACK and Adductor Canal Block after Knee Surgeries

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: January 10, 2025
• Primary Completion: July 10, 2025
• Study Completion: August 10, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)