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

ConditionAnalgesia, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control group

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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). )

Treatment groups

111 Participants
are divided into 3 treatment groups
Group A: Control group (group C)Active comparator 1 intervention
Group B: Fentanyl group (group F)Active comparator 1 intervention
Group C: Dexmedetomidine group (group D)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

● The total amount of rescue analgesic consumption (tramadol)

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

Time frame
For 48 hrs
2

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)

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

Secondary outcomes

1

The time to first request of rescue analgesia (tramadol)

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

Time frame
24 hours postoperative
2

The length of hospital stays

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

Time frame
For 48-72 hrs
3

The incidence of adverse events

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

Time frame
For 48 hrs
4

patient's satisfaction

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)

Time frame
For 48 hrs

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

faculty of human medicine, Zagazig university hospitalsRecruiting El SharkiaEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov
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