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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Morphine consumption
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Pericapsular nerve group block plus intrathecal bupivacaine (Drug)
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.
Intervention: Intrathecal bupivacaine and morphine (Drug)
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.
Intervention: Pericapsular nerve group block plus intrathecal bupivacaine and morphine (Drug)
Outcomes
Primary Outcomes
Morphine consumption
Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours
Morphine
Secondary Outcomes
- Postoperative pain scores(From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours)
- The quality of recovery score(From beginning of anesthesia (15 minutes before anesthesia) to after 24 hours, up to 24hours)
Investigators
Saadet Oztop
Principal Investigator
Bezmialem Vakif University