Trial · Interventional

CompletedNot applicableResults postedRegistry data

A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty

NCTNCT06284941Other idKY 2023-001-001

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 90 participants (actual)
Sponsor: Wang wanxia · Other
Design: Randomized · Double masking
Countries: 1 country
China
Start: 20 Jun 2023
Primary completion: 28 Feb 2024
Completion: 28 Feb 2024
First posted: 29 Feb 2024
Last update posted: 4 Feb 2025
Conditions: Femoral Neck Disease

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

N/A
A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty
NCT06284941
20 Jun 2023 to 28 Feb 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Ropivacaine combined with methylene blue for iliac fascia blockDrug

Arms2

No intervention
0.25% ropivacaine 30ml for iliac fascia block
Experimental
0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block

Primary outcomes1

Outcomes the sponsor listed as primary.

Visual Analogue Scale（VAS）
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
Registry description
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 outcomes(9)

Hypersensitive C-reactive Protein
Time frame · From enrollment to 48 hours after surgery
Registry description
Hypersensitive C-reactive protein, like procalcitonin, is an inflammatory marker. Both have the same meaning and are used to reflect the postoperative analgesic effect
Procalcitonin
Time frame · From enrollment to 48 hours after surgery
Registry description
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
Time frame · From enrollment to 48 hours after surgery
Mean Arterial Pressure
Time frame · From entering the operating room to leaving the resuscitation room
Heart Rate
Time frame · From entering the operating room to leaving the resuscitation room
Duration of Surgery
Time frame · Intraoperative
Number of Postoperative Salvage Analgesia
Time frame · From the end of surgery to 48 hours after surgery
Walking Distance for the First Time Getting Out of Bed
Time frame · From the end of surgery to 48 hours after surgery
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 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

Visual Analogue Scale（VAS）

Group	Value (score)
0.25% Ropivacaine 30ml for Iliac Fascia Block	3.0
0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block	4.0

Secondary and other outcome results(7)

Secondary outcome· From enrollment to 48 hours after surgery

Hypersensitive C-reactive Protein

Group	Value

Secondary outcome· From enrollment to 48 hours after surgery

Procalcitonin

Group	Value

Secondary outcome· From enrollment to 48 hours after surgery

Neutrophil Lymphocyte Ratio

Group	Value

Secondary outcome· From entering the operating room to leaving the resuscitation room

Mean Arterial Pressure

Group	Value

Secondary outcome· From entering the operating room to leaving the resuscitation room

Heart Rate

Group	Value

Secondary outcome· Intraoperative

Duration of Surgery

Group	Value

Secondary outcome· From the end of surgery to 48 hours after surgery

Number of Postoperative Salvage Analgesia

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
0.25% Ropivacaine 30ml for Iliac Fascia BlockFascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine	0 / 45	0 / 45	7 / 45
0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia BlockRopivacaine combined with methylene blue for iliac fascia block: Ultrasound guided iliac fascia block, administered with 30ml of 0.25% ropivacaine+0.05% methylene blue	0 / 45	0 / 45	6 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedZhang Y, Yang S, Lu ZR, Zhou F, Liu MY. Analgesic effect of ropivacaine combined with methylene blue in fascia Iliaca block for patients undergoing hip arthroplasty. BMC Musculoskelet Disord. 2025 Mar 14;26(1):256. doi: 10.1186/s12891-025-08490-6. PMID 40087701

Eligibility

Who could join, as posted.

Sex: All
Age: from 65 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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