The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty

Not Applicable

Recruiting

• Conditions: Postoperative Pain Management
• Interventions: Drug: Pericapsular nerve group block plus intrathecal bupivacaine and morphine; Drug: Pericapsular nerve group block plus intrathecal bupivacaine; Drug: Intrathecal bupivacaine and morphine

• Registration Number: NCT06298370
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone.

Detailed Description

Effective postoperative pain control in hip surgeries can reduce complications and improve postoperative care. Multimodal analgesic techniques in postoperative pain management are employed to synergistically target different nociceptive mechanisms. Combining peripheral nerve blocks with low-dose intrathecal opioids can decrease the systemic opioid dose. Additionally, side effects associated with opioids, such as sedation, respiratory depression, nausea, vomiting, rash, and urinary retention, can be mitigated by the combination with peripheral nerve blocks.

The addition of Pericapsular Nerve Group (PENG) block to a multimodal analgesia regimen has been shown to significantly enhance the quality of recovery and reduce opioid consumption in patients undergoing hip arthroplasty.

The Quality of Recovery (QoR-15), developed and validated by Stark et al. in 2013, is a recovery scale indicating postoperative recovery quality. It includes 15 questions assessing pain, physical comfort, physical independence, psychological support, and emotional state, providing a score between 0 and 150, where a higher score indicates better recovery quality.

In anterior hip surgeries, it is anticipated that spinal anesthesia combined with PENG block and low-dose intrathecal morphine will result in lower postoperative morphine consumption and pain scores compared to PENG alone and intrathecal morphine alone over the first 48 hours. Furthermore, it is expected that the quality of recovery (QoR-15 score) will be higher, providing patients with a longer pain-free period, early mobilization, and improved recovery quality.

Study Timeline

• Study First Submitted: 2024-02-03
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Study Start: 2024-03-18
• Primary Completion: 2024-06-08
• Study Completion: 2024-07-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Aged between 18 and 90 years
• American Society of Anesthesiologists (score ranging from 1 to 4)
• Anterior hip arthroplasties

Exclusion Criteria

• Patients with a history of opioid addiction
• Individuals under the age of 18
• Those aged 90 and above
• Allergies to morphine, fentanyl, bupivacaine, or tramadol
• Coagulopathy
• Infection at the injection site
• Severe cardiac, renal, or hepatic dysfunction
• Cases unable to provide informed consent
• Body Mass Index >40 kg/m2
• Known neurological or anatomical deficits in the lower extremities
• Patients requiring a transition from spinal anesthesia to general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P+M	Pericapsular nerve group block plus intrathecal bupivacaine and morphine	Patients will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal bupivacaine plus morphine. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a 22 Gauche 80 mm block needle. Intrathecal drugs will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine.
Group P	Pericapsular nerve group block plus intrathecal bupivacaine	Patients in this group will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal bupivacaine. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a 22 Gauche 80 mm block needle. Subsequently, intrathecal drug will be administered at the L3-L4 intervertebral level with 10-15 mg of bupivacaine while the patient is in a sitting position.
Group M	Intrathecal bupivacaine and morphine	Patients will receive intrathecal bupivacaine plus morphine without Pericapsular Nerve Group block. Intrathecal drugs will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine.

Primary Outcome Measures

Name	Time	Method
Morphine consumption	From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours	Morphine

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours	Visual Analog Scale (Minimum value: 0- Maximum value:10) 0: No pain, 10: the most intense pain imaginable. Lower scores mean better outcomes and higher scores mean worse outcome.
The quality of recovery score	From beginning of anesthesia (15 minutes before anesthesia) to after 24 hours, up to 24hours	The quality of recovery (QoR-15 score): It includes 15 questions assessing pain, physical comfort, physical independence, psychological support, and emotional state, providing a score between 0 and 150, where a higher score indicates better recovery quality.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey