Clinical trial NCT06298370: The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain Management
Keywords: Postoperative pain
Intrathecal morphine
Intrathecal bupivacaine
Hip arthroplasty
Pericapsular nerve group block
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, double-blind, randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption
timeFrame: From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours
measure: The quality of recovery score
timeFrame: From beginning of anesthesia (15 minutes before anesthesia) to after 24 hours, up to 24hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Saadet Oztop, MD
role: PRINCIPAL_INVESTIGATOR
References: