Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06298370
Acronym
PENG
Enrollment
3
Registered
2024-03-07
Start date
2024-03-18
Completion date
2024-07-08
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain Management

Keywords

Postoperative pain, Intrathecal morphine, Intrathecal bupivacaine, Hip arthroplasty, Pericapsular nerve group block

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.

Interventions

DRUGPericapsular 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.

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.

DRUGPericapsular 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.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

prospective, double-blind, randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumptionFrom end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hoursMorphine

Secondary

MeasureTime frameDescription
Postoperative pain scoresFrom end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hoursVisual 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 scoreFrom beginning of anesthesia (15 minutes before anesthesia) to after 24 hours, up to 24hoursThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSaadet MD Oztop, MD
soztop@bezmialem.edu.tr+905067861993
Backup ContactAyhan Dalak
adalak@bezmialem.edu.tr+905301730123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026