PENG Block Versus Intrathecal Morphine for Early Postoperative Recovery After Total Hip Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorErzincan Binali Yildirim Universitesi

About this trial

The goal of this clinical trial is to compare the PENG block with intrathecal morphine for early postoperative recovery and pain control in adults undergoing elective total hip arthroplasty. The main question it aims to answer is:

Is there a difference between PENG block and intrathecal morphine in quality of recovery 24 hours after surgery, as measured by the Quality of Recovery-15 (QoR-15) questionnaire?

Researchers will also compare postoperative pain, opioid use, mobilization, motor function, and treatment-related side effects between the two groups.

Participants will be randomly assigned to receive either a PENG block or intrathecal morphine in addition to spinal anesthesia and standard multimodal pain treatment. Participants will complete the QoR-15 questionnaire before surgery and 24 hours after surgery. Pain scores, opioid use, mobilization, motor function, and side effects will be assessed during the first 24 hours after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-85 years

American Society of Anesthesiologists (ASA) physical status I-III

Scheduled for elective primary unilateral total hip arthroplasty

Planned spinal anesthesia

Disqualifiers

Contraindication to spinal anesthesia or PENG block

Known allergy or hypersensitivity to local anesthetics or morphine

Coagulation disorder

Therapeutic anticoagulant use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pericapsular nerve group (PENG) block

    Procedure/Surgery

    Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia. The total injectate volume will be 20 mL, with an intended dose of 100 mg bupivacaine (20 mL of 0.5% bupivacaine). The bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, 0.9% saline will be added to maintain a total injectate volume of 20 mL.

  • Intrathecal Morphine

    Drug

    100 micrograms of preservative-free morphine administered intrathecally during spinal anesthesia

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: PENG Block GroupExperimental treatment 1 intervention
Group B: Intrathecal Morphine GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery

Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery. The questionnaire will be administered preoperatively to assess baseline recovery status and repeated 24 hours after surgery. The primary outcome will be the QoR-15 score at 24 hours after surgery.

Time frame
24 hours after surgery

Secondary outcomes

1

Pain at Rest Assessed by the Numeric Rating Scale (NRS)

Pain at rest will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A preoperative measurement will be obtained as the baseline value, and postoperative measurements will be compared with baseline and between the study groups.

Time frame
Preoperatively and at 3, 6, 12, and 24 hours after surgery
2

Pain During Straight Leg Raise Assessed by the Numeric Rating Scale (NRS)

Pain during active straight leg raise will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A preoperative measurement will be obtained as the baseline value, and postoperative measurements will be compared with baseline and between the study groups.

Time frame
Preoperatively and at 3, 6, 12, and 24 hours after surgery
3

Cumulative Postoperative Opioid Consumption

Total opioid consumption during the first 24 hours after surgery will be recorded. Administered opioids will be converted to intravenous morphine-equivalent doses for comparison between groups.

Time frame
From the end of surgery to 24 hours after surgery
4

Time to First Postoperative Mobilization

Time from the end of surgery to the participant's first postoperative mobilization will be recorded.

Time frame
From the end of surgery to first mobilization, assessed up to 24 hours after surgery

Other outcomes

Sponsors and contacts

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

Erzincan Binali Yildirim Universitesi

Lead sponsor

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

Sponsor institution

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