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

Postoperative Pain Management Clinical Trial

— PENG  

Official title:

The Efficacy of Combined Intrathecal Morphine and Pericapsular Nerve Group (PENG) Block on Postoperative Pain and Recovery Quality in Anterior Hip Arthroplasty: A Prospective, Double-blind, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298370
• Other study ID #: PENG study
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: July 8, 2024

Study information

• Verified date: March 2024
• Source: Bezmialem Vakif University
• Contact: Saadet MD Oztop, MD
• Phone: +905067861993
• Email: soztop[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: July 8, 2024
• Est. primary completion date: June 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management

Intervention

Drug:
• Pericapsular nerve group block plus intrathecal bupivacaine
Patients 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 bupivacaine will be administered at the L3-L4 intervertebral level with 10-15 mg bupivacaine while the patient is in a sitting position.The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.
• Intrathecal bupivacaine and morphine
Patients will receive intrathecal bupivacaine and 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. The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.
• 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 drugs. 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 S22 Gauche 80 mm block needle. Subarachnoid block will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 µg of morphine. The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Morphine	From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours
Secondary	Postoperative pain scores	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.	From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours
Secondary	The quality of recovery score	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.	From beginning of anesthesia (15 minutes before anesthesia) to after 24 hours, up to 24hours