Skip to main content
OpenTrials
Completed

NCT Number: NCT05979597

The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in SFIB

The investigators aimed to demonstrate that dexamethasone added as an adjuvant to local anaesthetic agent in suprainguinal fascia iliaca block for effective postoperative analgesia after knee arthroplasty would prolong the duration of sensory block and reduce postoperative pain intensity and analgesic consumption.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

About this study

Total knee arthroplasty is one of the major orthopedic surgeries that cause severe postoperative pain. A successful post-operative outcome is possible with strong and effective pain control followed by early mobilization and a good functional recovery. Suprainguinal fascia iliaca plan block (SFIB) has been shown to be an effective postoperative method in multimodal analgesia regime in lower extremity surgery. It has been reported in the literature that dexamethasone added to local anaesthetics in peripheral nerve blocks prolongs the duration of sensory block, improves the quality of analgesia, reduces postoperative pain intensity and opioid consumption.

In this study, the investigators aimed to demonstrate that dexamethasone added as an adjuvant to local anaesthetic agent in SFIB for effective postoperative analgesia after knee arthroplasty would prolong the duration of sensory block and reduce postoperative pain intensity and analgesic consumption.

An identification number will be randomly assigned to each participants, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, participants will be followed up with these numbers. Which group the participants will be included in will be determined by the closed envelope method.

Participants undergoing unilateral knee arthroplasty will be included in the study. Following the end of surgery, the participants will be divided into two groups in the recovery room and SFIB will be applied to both groups. Participants in group SFIB will receive 0.25% bupivacaine as local anaesthetic. Participants in group SFIB+dexamethasone will receive 0.25% bupivacaine as local anaesthetic and 8 mg dexamethasone as adjuvant.

The participant with the block will be followed in the recovery room and if the block is successful, morphine patient controlled analgesia (PCA) treatment will be started and the participant will be taken to the ward. A standard analgesia regimen (1 g iv paracetamol every 8 hours, 50 mg iv dexketoprofen every 12 hours) was used in all participants.

Evaluation of postoperative pain will be done with numerical rating scale (NRS). Pain levels will be questioned in two different ways as rest and passive moving.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having undergone unilateral knee replacement surgery under elective conditions,
  • Age range of 18-75 years,
  • American Society of Anesthesiologist's physiologic state I-III patients,
  • written consent who agreed to participate in the study.

Exclusion criteria

  • BMI>35
  • who do not want to be included in the study by not signing the voluntary consent form,
  • Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found,
  • Coagulopathy, hepatic or renal failure,
  • Allergic to a local anesthetic agent or one of the drugs used in the study,
  • Having a history of chronic opioid and corticosteroid use,
  • who cannot use the patient-controlled analgesia system and have a psychiatric disease,
  • with operative time less than 20 minutes and more than 120 minutes for better standardization of studies.

Treatment and study plan

suprainguinal fascia iliaca block

Procedure

After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.

Suprainguinal fascia iliaca block+dexamethasone

Procedure

After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic+dexamethasone injection will be made between the fascia and the muscle.

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: Postoperative 24 hours

    First 24 hours total morphine consumption with patient controlled analgesia

Secondary outcomes

  1. Numerical Rating Scale

    Time frame: Postoperative 24 hours

    To determine the pain of the patients at rest and passive-active moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.

  2. Timed up and go test (TUG)

    Time frame: at 24th hour

    TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again

  3. Quadriceps muscle strength

    Time frame: at 24th hour

    will be evaluated in a scale between 1-5 (1:lowest; 5:normal)

Sponsors and collaborators

Lead sponsor

Samsun Education and Research Hospital

Other

Registry information

Official study title

The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in Suprainguinal Fascia Iliaca Block (SFIB) in Knee Arthroplasty

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Apr 11, 2024

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.

Published trials that share one or more normalized conditions with this study.