Status Approved
First Submitted Date
2021/02/17
Registered Date
2021/03/31
Last Updated Date
2021/02/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006049 |
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Unique Protocol ID | CNUH 2020-04-013 |
Public/Brief Title | A comparison of the analgesic efficacy of pericapsular nerve group blocking vs periarticular injection after total hip arthroplaslty - Prospective study - |
Scientific Title | A comparison of the analgesic efficacy of pericapsular nerve group blocking vs periarticular injection after total hip arthroplaslty - Prospective study - |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CNUH 2020-04-013 |
Approval Date | 2020-07-16 |
Institutional Review Board Name | Chungnam National University Hospital Institutional Review Board |
Institutional Review Board Address | 282, Munhwa-ro, Jung-gu, Daejeon |
Institutional Review Board Telephone | 042-280-8715 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Deuk Soo Hwang |
Title | Professor |
Telephone | +82-42-338-2480 |
Affiliation | Chungnam National University Hospital |
Address | Chungnam National University Hospital, 282 Munwha-ro, Jung-gu, Daejeon 35015, Republic of Korea |
Contact Person for Public Queries | |
Name | Jeong Kil Lee |
Title | Professor |
Telephone | +82-42-338-2480 |
Affiliation | Chungnam National University Sejong Hospital |
Address | 20, Bodeum 7-ro, Sejong-si, Republic of Korea |
Contact Person for Updating Information | |
Name | Jeong Kil Lee |
Title | Professor |
Telephone | +82-42-338-2480 |
Affiliation | Chungnam National University Sejong Hospital |
Address | 20, Bodeum 7-ro, Sejong-si, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2020-07-16 Actual | |
Target Number of Participant | 60 | |
Primary Completion Date | 2021-02-28 , Anticipated | |
Study Completion Date | 2021-02-28 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chungnam National University Hospital | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2020-07-16 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Chungnam National University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chungnam National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Pain after surgery is one of the most common reasons for delayed discharge. The pain of total hip arthroplasty is so severe that it may not only cause pain to the patient after surgery, but may also lead to fear of surgery. Pain can slow the recovery of joint motion after rehabilitation and surgery, which may lead to less than expected range of motion, and fear of surgery may interfere with the formation of a relationship between the patient and the doctor. For this reason, various methods have been attempted to reduce postoperative pain, but there is no established method due to utility problems and side effects. In this study, the effect of postoperative pain control in patients who underwent total hip arthroplasty surgery compared the group who underwent preoperative Nerve block surgery around the joint capsule and the group who underwent an anesthetic injection into the joint capsule during surgery. The goal is to find a more effective postoperative pain control method by performing an anesthetic injection into the joint capsule, which has already proven effective in total hip arthroplasty, and setting it as a comparative group, and setting the recently emerged nerve group blockage around the hip as an experimental group. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | /Procedure/Surgery |
Intervention Description | An anesthetic in the experimental group was injected between the psoas tendon and the pubic ramus with a mixture of 20 ml of ropivacaine and 10 ml of normal saine while watching ultrasound. The mixture of the comparative group is prepared by mixing 20 ml of ropivacaine, 2 ml of ketorolac, and 1 ml of epinephrine with physiological saline to make 100 cc and dividing into two 50 cc syringes. Inject it into the subcutaneous before skin incision, into the posterior capsule before capsectomy, and into the anterior capsule before inserting the femoral stem. After surgery, before stitching the surgical site, the remaining mixture is injected into the soft tissue around the surgical site and layer by layer suture is performed. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental group |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description An anesthetic in the experimental group was injected between the psoas tendon and the pubic ramus with a mixture of 20 ml of ropivacaine and 10 ml of normal saine while watching ultrasound. |
|
Arm 2 |
Arm Label Comparative group |
Target Number of Participant 30 |
|
Arm Type Active comparator |
|
Arm Description The mixture of the comparative group is prepared by mixing 20 ml of ropivacaine, 2 ml of ketorolac, and 1 ml of epinephrine with physiological saline to make 100 cc and dividing into two 50 cc syringes. Inject it into the subcutaneous before skin incision, into the posterior capsule before capsectomy, and into the anterior capsule before inserting the femoral stem. After surgery, before stitching the surgical site, the remaining mixture is injected into the soft tissue around the surgical site and layer by layer suture is performed. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M25.95)Joint disorder, unspecified, pelvic region and thigh Hip, Osteoarthritis, Hip Replacement |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description 1) Men and women over 18 years of age 2) Patients who underwent total hip arthroplasty under the diagnosis of arthritis after the IRB approval date 3) Patients who have completed the survey among patients admitted to the hospital for more than 48 hours after surgery |
|
Exclusion Criteria |
1) Patients who were hospitalized for more than 48 hours after surgery and did not faithfully participate in the survey, or were discharged within 48 hours unplanned and failed to complete the survey 2) Patients who have undergone total hip arthroplasty due to reoperation, infectious disease, or fracture rather than simple total hip arthroplasty. 3) Patients with side effects related to nerve group blockage before surgery or periarticular capsule injection during surgery 4) Patients with diseases such as delirium/dementia are excluded 5) If the patient does not agree to participate in the test |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | clinical-equivalence | |
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Primary Outcome(s) 1 | ||
Outcome | Statistically analyzed whether there was a significant difference in the degree of pain reduction between the experimental group and the control group. |
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Timepoint | Measure and evaluate the change in pain score for 48 hours after surgery |
|
Secondary Outcome(s) 1 | ||
Outcome | Statistical analysis was made to see if there was a significant difference in the quality of recovery between the experimental group and the control group, and whether the shortening of hospitalization period accordingly occurred. |
|
Timepoint | Measure the quality of recovery after surgery and evaluate the hospitalization period until discharge |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2021. 12 |
Way of Sharing | To be made available at a later date
(myhomejungle@hanmail.net) |
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