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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Pericapsular nerve group block plus intrathecal bupivacaine; Drug: Intrathecal bupivacaine and morphine; Drug: Pericapsular nerve group block plus intrathecal bupivacaine and morphine

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 Type: Interventional
• Enrollment (Estimated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saadet MD Oztop, MD; Phone Number: +905067861993; Email: soztop@bezmialem.edu.tr
• Study Contact Backup: Name: Ayhan Dalak; Phone Number: +905301730123; Email: adalak@bezmialem.edu.tr

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Recruiting
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P; 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.	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.; Other Names: Spinal anesthesia; Peripheric nerve block
Active Comparator: Group M; 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.	Drug: 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.; Other Names: Spinal anesthesia
Active Comparator: Group P+M; 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.	Drug: 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.; Other Names: Spinal anesthesia; Peripheric nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Morphine	From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Saadet Oztop, MD, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2024
• Primary Completion (Estimated): June 8, 2024
• Study Completion (Estimated): July 8, 2024

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intrathecal morphine; Postoperative pain; Hip arthroplasty; Pericapsular nerve group block; Intrathecal bupivacaine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics, Local; Anesthetics; Bupivacaine; Morphine
• Other Study ID Numbers: PENG study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No