Pain, Postoperative Clinical Trial
Official title:
Suprainguinal Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block for Analgesia After Total Hip Arthroplasty: a Randomized Controlled Trial
Verified date | December 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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 |
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