Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05228028
Other study ID # 2112-062-1282
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2022
Est. completion date December 22, 2022

Study information

Verified date December 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca compartement block [FICB] group or quadratus lumborum block [QLB] group). In the FICB group, ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is performed on the ipsilateral surgical side at the end of surgery. In the QLB group, ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery. A standardized multimodal analgesic regimen is used for postoperative pain control. The total use of opioids including patient-controlled analgesia and rescue analgesics is compared in both groups for 24 hours after surgery. The amount of opioids used is compared by conversion to oral morphine equivalent dose. Pain score at rest and movement during postoperative 24 hours, time to first request for analgesics, the incidence of side effects, patient satisfaction for pain control at postoperative 24 hours, quality of recovery at postoperative 24 hours, time to discharge readiness, and hospital length of stay are compared.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 22, 2022
Est. primary completion date October 21, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: - Adult patients between the ages of 19 and 70 undergoing total hip arthroplasty under spinal anesthesia - Be able to provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and be able to properly fill out patient-reported questionnaires - ASA physical status classification 1-2 Exclusion Criteria: - ASA physical status classification 3-4 - Patients who are contraindicated to nerve blocks (hypersensitivity to local anesthetics, infection at the injection site, etc.) - Patients with chronic pain and taking pain medications, antidepressants, and anticonvulsants - Other major medical or psychiatric conditions that will affect response to treatment - Refusal of intravenous patient-controlled analgesia - Patients determined to be unsuitable for this clinical trial by the researchers

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
fascia iliaca compartement block
Ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
quadratus lumborum block
Ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total opioids use for 24 hours Total dose of opioids used upto 24 hours after surgery (morphine milligram equivalents) Over the first 24 hours after surgery
Secondary Postoperative pain at rest (Numeric rating scale) Postoperative pain at rest (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain) At postoperative 4, 8, 12, 16, 20, 24 hours
Secondary Postoperative pain with movement (Numeric rating scale) Postoperative pain with movement (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain) At postoperative 4, 8, 12, 16, 20, 24 hours
Secondary Time to first request for pain medication Time to first request for pain medication after surgery From the end of surgery to discharge, an average of 4 days
Secondary Incidence of postoperative nausea and vomiting Incidence of postoperative nausea and vomiting (%) Over the first 24 hours after surgery
Secondary Patient satisfaction score with pain control at 24 hours after surgery Patient satisfaction score with pain control at 24 hours after surgery (minimum 0, maximum 10, a higher score means higher satisfaction) At 24 hours after surgery
Secondary Quality of Recovery at 24 hours after surgery Quality of Recovery at 24 hours after surgery assessed by QoR-15 questionnaire At 24 hours after surgery
Secondary Time to discharge readiness Days of hospitalization after surgery until discharge readiness (defined as satisfying the following three criteria; (1) adequate pain control (numeric rating scale score < 4), (2) no intravenous opioid use in the past 12 hours, and (3) able to walk at least 30 m without time limit) From the end of surgery to discharge, an average of 4 days
Secondary Hospital length of stay Days of hospitalization after surgery until discharge From the end of surgery to discharge, an average of 4 days
See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2