Trial Outcomes & Findings for A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty (NCT NCT06284941)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

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

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	0.25% Ropivacaine 30ml for Iliac Fascia Block 0.25% ropivacaine 30ml for iliac fascia block	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
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.25% Ropivacaine 30ml for Iliac Fascia Block n=45 Participants Fascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine	0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block n=45 Participants 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	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Age, Continuous	75.47 Jiangyan District Hospital of traditiona STANDARD_DEVIATION 5.54 • n=5 Participants	73.93 Jiangyan District Hospital of traditiona STANDARD_DEVIATION 5.61 • n=7 Participants	74.7 Jiangyan District Hospital of traditiona STANDARD_DEVIATION 5.60 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	0.25% Ropivacaine 30ml for Iliac Fascia Block n=45 Participants Fascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine	0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block n=45 Participants 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
Visual Analogue Scale（VAS）	3.0 score Interval 2.0 to 3.5	4.0 score Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

0.25% Ropivacaine 30ml for Iliac Fascia Block

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.25% Ropivacaine 30ml for Iliac Fascia Block n=45 participants at risk Fascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine	0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block n=45 participants at risk 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
Gastrointestinal disorders Nausea and vomiting	15.6% 7/45 • The total time for collecting adverse events was approximately 48 hours, each participant was collected from the end of the surgery to 48h postoperatively.	13.3% 6/45 • The total time for collecting adverse events was approximately 48 hours, each participant was collected from the end of the surgery to 48h postoperatively.

Additional Information

Yang Zhang

Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine

Phone: 15861013918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place