Rotator Cuff Tears, Hemorrhage, Surgical, Shoulder Injuries
Conditions
Keywords
Arthroscopy, Hemorrhage, Shoulder, Tranexamic acid
Brief summary
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.
Detailed description
All surgical procedures will be performed at the University orthopaedic and trauma hospital Lovran, Croatia. Upon arrival at the hospital, the patient's body weight and height will be recorded. One day before the procedure, the patient will have blood taken from a vein and a complete blood count will be analyzed. Body weight and height were also recorded, and body mass index was calculated. Before the procedure, a physiotherapist measured the initial shoulder circumference in centimeters at three standardized measurement points: axilla-acromion (point A), axilla-deltoid (point B), and 10 cm above the olecranon (point C). The circumferences were documented on a standardized data collection form. Immediately before the procedure, patients will receive regional infiltrative (interscalene block) and general anesthesia with airway protection by endotracheal tube or laryngeal mask. Patients in the experimental group will receive 1 g of TXA in 100 ml of sterile saline IV 10 min before the start of the procedure, while patients in the control group will receive only sterile saline. The position of the patients will be beach chair with the head in the protective helmet and the arm in the front traction of 2,5 kg. All patients will be operated on by the same surgeon (NM) with the usual equipment: 4 mm 30° arthroscopic lens, arthroscopic pump basically set to 50 mmHg with the possibility of pulse increase of pressure by 20 mmHg for 2 min as needed, radiofrequency ablator and arthroscopic shaver system. Rotator cuff tendon repair will be performed using suture anchors as the primary procedure in all patients. If needed, additional procedures will be carried out, including glenohumeral (GH) stabilization by capsulolabral plication, labral repair, and long head of the biceps brachii (LHBB) tenodesis using the same implants. In cases of more severe damage or inflammation, LHBB tenotomy will be performed instead. Acromioclavicular (AC) joint repositioning and vertical stabilization will be performed using a suspensory fixation system with titanium buttons and synthetic tapes. Other possible procedures include subacromial and subcoracoid bursectomy with soft tissue release, acromioplasty, tuberoplasty, AC joint resection, capsulotomy, synovectomy, microfracture (MFX), paralabral cyst evacuation, tendon drilling, removal of calcifications or implants, and tissue or implant sampling for histological and microbiological analysis. At the beginning of surgery and every 15 minutes thereafter, the surgeon will assess arthroscopic visibility using a Visual Analogue Scale (VAS-V) ranging from 0 (worst) to 10 (best), while being blinded to TXA allocation. Simultaneously, the endoscopic screen will be photographed with a 40 MP camera. Scores will be recorded, and images stored. Screen photos will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation (VAS range 0-10). Intraoperative data will include the number and extent of tendon lesions, presence of synovitis, operative time, mean arterial pressure (MAP), number of irrigation pressure boosts, and fluid inflow/outflow volumes. All procedures and implants will be documented. Any intraoperative complications (e.g., camera fogging, implant/instrument failure) will be noted. All administered crystalloids/colloids will be listed. Irrigation waste fluid will be collected and homogenized, and a 20 mL sample will be taken for analysis. Hemoglobin concentration will then be determined in the homogenized sample using spectrophotometry (Cripps method; University of Rijeka, Medical Faculty; Varian Cary 100 Bio, 190-900 nm, resolution ≤ 0.189 nm, wavelength accuracy ± 0.02-0.04 nm). On the first day after the surgery, the shoulder circumference will be measured at 3 typical sites and the level of pain will be noted (VAS range 0 no pain -10 the strongest pain). On the second day, the shoulder circumference measurement and estimation of the level of pain will be repeated. Also blood will be taken from a vein and complete blood count will be repeated. During the postoperative period, the amount and type of analgesic drugs administered and the length of hospitalization will be monitored.
Interventions
Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline.
DRUGPlacebo
Patients from experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline.
Sponsors
Nikola Matejcic
University orthopaedic and trauma hospital Lovran
University of Rijeka, The Faculty of Medicine
University of Zagreb, The Faculty of Kinesiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- rotator cuff tear
Exclusion criteria
* allergy to tranexamic acid, paracetamol (acetaminophen), ketoprofen, tramadol or metamizole sodium * deep vein thrombosis * congenital thrombophilia * coagulopathy * thromboembolic events within the previous 12 months * stroke or acute coronary syndrome within the previous 3 months * renal failure * liver cirrhosis * glaucoma or retinal vascular disorder * chronic treatment with anticoagulant or antiplatelet therapy * uncontrolled hypertension (systolic blood pressure \> 180 mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative) | From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes | The operating surgeon evaluated intraoperative visual clarity using the Visual Analog Scale for visibility (VAS-V), ranging from 0 (worst visual clarity) to 10 (best visual clarity), at 15-minute intervals during shoulder arthroscopy. At each assessment time point, the endoscope screen was simultaneously photographed. The surgeon was blinded to group allocation. Visual clarity assessments performed from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, all intraoperative VAS-V measurements within this period were averaged to obtain a single mean intraoperative visibility score. Higher scores indicate better visual clarity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Independent Assessor Visibility Rating (VAS) | From skin incision to final suture (intraoperative period), up to 135 minutes; image assessments performed after completion of surgery | Three blinded independent assessors evaluated standardized arthroscopic images projected on a screen using the Visual Analog Scale (VAS), ranging from 0 (no visibility) to 10 (optimal visibility). Images were obtained intraoperatively at predefined 15-minute time points during shoulder arthroscopy. Only images obtained from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, visibility ratings from all assessors and time points within this period were averaged to obtain a single mean visibility score. Higher scores indicate better visibility. |
| Interobserver Agreement of Independent Assessors for Arthroscopic Visibility Ratings (VAS) | After completion of surgery, following blinded assessment of standardized intraoperative arthroscopic images obtained from skin incision to final suture. | Agreement among three blinded independent assessors evaluating standardized intraoperative arthroscopic images using the Visual Analog Scale (VAS), ranging from 0 (worst visual clarity) to 10 (best visual clarity), was assessed using Cronbach's alpha. Images obtained from skin incision up to 135 minutes of surgery were included in the analysis. |
| Comparison of Arthroscopic Visibility Ratings Between the Operating Surgeon and Independent Assessors (VAS) | From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes; independent image evaluations performed after completion of surgery | Mean arthroscopic visibility ratings assessed using the Visual Analog Scale (VAS), ranging from 0 (no visibility) to 10 (optimal visibility), were evaluated intraoperatively by the operating surgeon at 15-minute intervals during shoulder arthroscopy and by three blinded independent assessors using standardized intraoperative arthroscopic images. Only assessments obtained from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, visibility ratings within this period were averaged to obtain a single mean visibility score, and mean visibility ratings were compared between the experimental and control groups. |
| Number of Irrigation Pump Pressure-boost Events | From skin incision to final suture (intraoperative period) | The number of arthroscopic pump pressure-boost events, defined as transient increases in irrigation pressure of 20 mmHg sustained for a 2-minute period, was recorded throughout shoulder arthroscopy. For each participant, the total number of pressure-boost events occurring during the intraoperative period was recorded. |
| Total Irrigation Fluid Volume Used (L) | From skin incision to final suture (intraoperative period) | The total volume of irrigation fluid used during shoulder arthroscopy was recorded throughout the surgical procedure. For each participant, the cumulative irrigation fluid volume used during the intraoperative period was calculated and expressed in liters. |
| Intraoperative Mean Arterial Pressure (MAP), mmHg | From skin incision to final suture (intraoperative period) | Mean arterial pressure (MAP) values were continuously recorded from the anesthesia machine throughout shoulder arthroscopy. For each participant, all intraoperative MAP measurements were averaged to obtain a single mean intraoperative MAP value, expressed in mmHg. |
| Duration of Surgery (Minutes) | From skin incision to final suture (intraoperative period) | The duration of surgery was recorded for each participant as the time from skin incision to final suture and expressed in minutes. |
| Intraoperative Blood Loss (mL) | From skin incision to final suture (intraoperative period) | Intraoperative blood loss was calculated for each participant based on hemoglobin concentration measured spectrophotometrically in homogenized waste irrigation fluid collected throughout shoulder arthroscopy, in combination with the total volume of irrigation fluid used during the intraoperative period. The result was expressed as total intraoperative blood loss in milliliters (mL). |
| Total Perioperative Blood Loss (mL) | From preoperative baseline (measured 1 day before surgery) to postoperative day 2 | Total perioperative blood loss was calculated using the Gross formula based on changes in hematocrit values from the preoperative baseline to postoperative day 2. |
| Postoperative (Hidden) Blood Loss (mL) | From completion of surgery (final suture) to postoperative day 2 | Postoperative (hidden) blood loss was calculated by subtracting the intraoperative blood loss from the total perioperative blood loss. |
| Perioperative Drop in Hemoglobin (g/dL) | From preoperative baseline (measured 1 day before surgery) to postoperative day 2 | The perioperative decrease in hemoglobin concentration was calculated as the difference between the preoperative baseline value and the value measured on postoperative day 2. |
| Change in Upper-arm Circumference (cm) as Marker of Swelling | From preoperative baseline (measured 1 day before surgery) to postoperative day 2 | Upper-arm circumference was measured using a measuring tape at three predefined anatomical points (A, B, and C) on the operated upper arm. Measurements were obtained preoperatively and on postoperative days 1 and 2. For each participant, measurements at points A, B, and C were averaged to obtain a single mean circumference value at each time point. Postoperative swelling was expressed as the change in mean upper-arm circumference from baseline to postoperative day 2. |
| Postoperative Pain (VAS, 0-10) | From postoperative day 1 to postoperative day 2 | Postoperative pain was assessed by the patient using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). Pain intensity was recorded on postoperative day 1 and postoperative day 2. For each participant, pain scores from postoperative days 1 and 2 were averaged to obtain a single mean postoperative pain score. Higher scores indicate greater pain intensity. |
| Total Postoperative Analgesic Consumption (mg) | From completion of surgery (final suture) until hospital discharge (postoperative inpatient period), up to 7 days | Total postoperative analgesic consumption was calculated as the cumulative dose of all orally and intravenously administered analgesics, including paracetamol (acetaminophen), ketoprofen, tramadol, and metamizole, from the end of surgery until hospital discharge. |
| Concentration of Hemoglobin in Waste Irrigation Fluid (mg/100 mL) | From skin incision to final suture (intraoperative period) | Hemoglobin concentration was determined spectrophotometrically from homogenized waste irrigation fluid samples collected throughout shoulder arthroscopy. For each participant, a single hemoglobin concentration value was obtained from the total collected irrigation fluid during the intraoperative period. |
| Length of Hospital Stay (Days) | From surgery until hospital discharge (postoperative inpatient period) | The length of hospital stay was recorded as the number of days each patient spent in the hospital following surgery until discharge. |
Countries
Croatia
Contacts
PRINCIPAL_INVESTIGATORNikola Matejcic, MD
University orthopaedic and trauma hospital Lovran, Croatia
Participant flow
Recruitment details
Participants were recruited and enrolled at a single orthopedic center. Recruitment began after institutional ethics approval on May 11, 2021, and continued until approximately June 2022. Eligible patients scheduled for arthroscopic shoulder surgery were screened and consecutively enrolled from May 24, 2021, to July 13, 2022, after meeting eligibility criteria and providing written informed consent.
Pre-assignment details
Of 121 enrolled participants 84 met inclusion criteria and were randomized to treatment
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment Croatia | 41 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 41 |
| other Total, other adverse events | 0 / 43 | 0 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 41 |
Outcome results
None listed