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NCT Number: NCT06759116

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

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of human medicine, Zagazig university hospitals

El Sharkia, Egypt

Location status: Recruiting

Location contact

SHERIF MOWAFY, MD

CONTACT

[email protected]

01003523374 ext. 002

Sherine Abd Ellatif, MD

CONTACT

01007948840 ext. 002

About this study

  • To measure the total amount of rescue analgesic consumption in the first 48 hours post-operatively in each group
  • To assess pain score in each group by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points: PACU, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs.
  • To measure the time of first request of rescue analgesia in each group
  • To record the incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting) and length of hospital stay.
  • Over all patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

1 - 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)

Exclusion criteria

. 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.

4.Chronic opioid use (more than 3 months or daily oral morphine > 5 mg /day for 1 month)

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Treatment and study plan

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)

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)

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). )

Primary outcomes

  1. ● The total amount of rescue analgesic consumption (tramadol)

    Time frame: For 48 hrs

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

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

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

    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)

Secondary outcomes

  1. The time to first request of rescue analgesia (tramadol)

    Time frame: 24 hours postoperative

    The time to first request of rescue analgesia (tramadol) (time from end of local anesthetics injection till time of NRS ≥ 3)

  2. The length of hospital stays

    Time frame: For 48-72 hrs

    The length of hospital stays (number of hospital stay days starting from discharge from PACU till discharge home).

  3. The incidence of adverse events

    Time frame: For 48 hrs

    The incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting).

  4. patient's satisfaction

    Time frame: For 48 hrs

    patient's satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Sadek Salem, MD

CONTACT

[email protected]

01099333513 ext. 002

Sherif Mowafy, MD

CONTACT

[email protected]

01003523374 ext. 002

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Analgesic Effect of Fentanyl Vs Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block After Knee Surgeries

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 14, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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