Femoral Neck Disease
Conditions
Brief summary
Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods.
Interventions
Ultrasound guided iliac fascia block, administered with 30ml of 0.25% ropivacaine+0.05% methylene blue
Sponsors
Wang wanxia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Hip replacement surgery is indicated * ASA Class II - Class III * No history of analgesic or local anesthetic allergy * No history of alcohol abuse or narcotic drug abuse * Patients and their families have given informed consent and signed the informed consent form
Exclusion criteria
* Patient or family refusal to participate in the study * Severe coagulation abnormalities * Local anesthetic allergy * Severe psychiatric illness or other communication disorder * There is an infection at the puncture site * History of neurological disease such as Guillain-Barré syndrome * Delay in awakening post-surgery for more than 60 min, * Post-surgical use of an analgesic pump * Inability to follow-up at the required time points.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale（VAS） | From enrollment to 48 hours after surgery， the VAS scores at both rest and with activity (passive straight leg raise at 45°) were recorded at the following time points: before block and at 2, 6, 12, 24, and 48 h postoperatively | Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and 0 and 10 at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procalcitonin | From enrollment to 48 hours after surgery | Procalcitonin is an inflammatory marker, which is associated with postoperative pain, the higher the degree of pain, the higher the procalcitonin value, the lower the pain level, and the lower the procalcitonin value, and the level of procalcitonin is used to reflect the postoperative analgesic effect |
| Neutrophil Lymphocyte Ratio | From enrollment to 48 hours after surgery | — |
| Mean Arterial Pressure | From entering the operating room to leaving the resuscitation room | — |
| Heart Rate | From entering the operating room to leaving the resuscitation room | — |
| Hypersensitive C-reactive Protein | From enrollment to 48 hours after surgery | Hypersensitive C-reactive protein, like procalcitonin, is an inflammatory marker. Both have the same meaning and are used to reflect the postoperative analgesic effect |
| Number of Postoperative Salvage Analgesia | From the end of surgery to 48 hours after surgery | — |
| Walking Distance for the First Time Getting Out of Bed | From the end of surgery to 48 hours after surgery | — |
| The Number of Activities of Getting Out of Bed 48 Hours After Surgery | From the end of surgery to 48 hours after surgery | — |
| Duration of Surgery | Intraoperative | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.25% Ropivacaine 30ml for Iliac Fascia Block Fascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine | 45 |
| 0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block Ropivacaine combined with methylene blue for iliac fascia block: Ultrasound guided iliac fascia block, administered with 30ml of 0.25% ropivacaine+0.05% methylene blue | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | 0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block | Total | 0.25% Ropivacaine 30ml for Iliac Fascia Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 90 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 73.93 Jiangyan District Hospital of traditiona STANDARD_DEVIATION 5.61 | 74.7 Jiangyan District Hospital of traditiona STANDARD_DEVIATION 5.6 | 75.47 Jiangyan District Hospital of traditiona STANDARD_DEVIATION 5.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 45 Participants | 90 Participants | 45 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 45 participants | 90 participants | 45 participants |
| Sex: Female, Male Female | 32 Participants | 62 Participants | 30 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 7 / 45 | 6 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Visual Analogue Scale（VAS）
Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and 0 and 10 at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain
Time frame: From enrollment to 48 hours after surgery， the VAS scores at both rest and with activity (passive straight leg raise at 45°) were recorded at the following time points: before block and at 2, 6, 12, 24, and 48 h postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 0.25% Ropivacaine 30ml for Iliac Fascia Block | Visual Analogue Scale（VAS） | 3.0 score |
| 0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block | Visual Analogue Scale（VAS） | 4.0 score |
Secondary
Duration of Surgery
Time frame: Intraoperative
Secondary
Heart Rate
Time frame: From entering the operating room to leaving the resuscitation room
Secondary
Hypersensitive C-reactive Protein
Hypersensitive C-reactive protein, like procalcitonin, is an inflammatory marker. Both have the same meaning and are used to reflect the postoperative analgesic effect
Time frame: From enrollment to 48 hours after surgery
Secondary
Mean Arterial Pressure
Time frame: From entering the operating room to leaving the resuscitation room
Secondary
Neutrophil Lymphocyte Ratio
Time frame: From enrollment to 48 hours after surgery
Secondary
Number of Postoperative Salvage Analgesia
Time frame: From the end of surgery to 48 hours after surgery
Secondary
Procalcitonin
Procalcitonin is an inflammatory marker, which is associated with postoperative pain, the higher the degree of pain, the higher the procalcitonin value, the lower the pain level, and the lower the procalcitonin value, and the level of procalcitonin is used to reflect the postoperative analgesic effect
Time frame: From enrollment to 48 hours after surgery
Secondary
The Number of Activities of Getting Out of Bed 48 Hours After Surgery
Time frame: From the end of surgery to 48 hours after surgery
Secondary
Walking Distance for the First Time Getting Out of Bed
Time frame: From the end of surgery to 48 hours after surgery