An interventional study of Simultaneous Bilateral Total Knee Replacement with Tourniquet and Simultaneous Bilateral Total Knee Replacement without Tourniquet in Arthroplasty, Replacement, Knee, Blood Loss, Surgical and Pain, Postoperative, sponsored by Shifa International Hospital. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Shifa International Hospital · Not applicable, Interventional, and Supportive care
This randomized controlled trial compared early outcomes after replacement of both knees during the same operation, with and without tourniquet use. A tourniquet was an inflatable cuff placed around the upper thigh and tightened during surgery to temporarily restrict blood flow. The study tested the hypothesis that tourniquet use would reduce blood loss during and after surgery, preserve hemoglobin levels, and reduce early postoperative pain. Hemoglobin was the protein in red blood cells that carried oxygen.
The study was designed to include 84 patients aged 40-80 years at the Department of Orthopedic Surgery, Shifa International Hospital, Islamabad. Patients were randomly assigned to two equal groups of 42. One group underwent replacement of both knees with tourniquet use, while the other underwent the same procedure without tourniquet inflation. Both groups received standardized surgical care, pain management, blood clot prevention, and rehabilitation.
The outcomes assessed were blood loss during surgery, blood collected through drains from both knees during the first 24 hours after surgery, hemoglobin levels at 24 hours, and the decrease from preoperative hemoglobin levels. Pain in each knee was assessed at 24 and 48 hours using a scale from 0, indicating no pain, to 10, indicating the worst possible pain. These measurements were compared between the two groups to assess the effect of tourniquet use on early recovery.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 84 is close to the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →Shifa International Hospital is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients underwent simultaneous bilateral total knee replacement with pneumatic thigh tourniquets. Standardized perioperative care, pain management, thromboprophylaxis, and rehabilitation were provided.
Procedure: Simultaneous Bilateral Total Knee Replacement with Tourniquet
Patients underwent simultaneous bilateral total knee replacement without tourniquet inflation. Standardized perioperative care, pain management, thromboprophylaxis, and rehabilitation were provided.
Procedure: Simultaneous Bilateral Total Knee Replacement without Tourniquet
Both knees were replaced during a single anesthetic session using cemented components. A pneumatic tourniquet was placed around the proximal thigh of each limb and inflated to 100 mmHg above systolic blood pressure immediately before the incision for that limb. Tourniquet release and hemostasis followed the standardized surgical protocol.
Both knees were replaced during a single anesthetic session using cemented components. Tourniquet cuffs were not inflated. Hemostasis was maintained throughout surgery using electrocautery and standard surgical techniques.
Intraoperative Blood Loss
Blood loss was calculated as the volume collected in suction canisters minus irrigation fluid, plus blood absorbed in surgical gauzes. Gauze blood content was estimated from the difference between preoperative and postoperative weights, using 1 gram as equivalent to 1 milliliter. Blood loss from both knee procedures was combined and recorded in milliliters per patient.
Time frame: During surgery, from skin incision to skin closure for both knee procedures.
Postoperative Hemoglobin Level
Hemoglobin concentration was measured in a venous blood sample and reported in grams per deciliter. Values were compared between the tourniquet and non-tourniquet groups.
Time frame: At 24 hours after completion of surgery.
Hemoglobin Decline
Hemoglobin decline was calculated by subtracting the hemoglobin concentration measured 24 hours after surgery from the preoperative concentration. The difference was reported in grams per deciliter.
Time frame: From the preoperative assessment to 24 hours after completion of surgery.
Postoperative Pain at 24 Hours
Pain was assessed separately for each knee using a 10-centimeter visual analog scale, ranging from 0, indicating no pain, to 10, indicating the worst possible pain. The average of the right and left knee scores was calculated for each patient. Higher scores indicated greater pain.
Time frame: At 24 hours after completion of surgery.
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Shifa International Hospital