Tammachote 2013.
Methods | Partially blinded, randomized, controlled trial Computerized block randomization; sealed opaque envelopes Follow‐up: 12 weeks |
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Participants | Subjects: 59 participants enrolled (57 analysed and followed up to 12
weeks) from one university hospital: Thammasat University, Pathumthani,
Thailand Operation: primary total knee replacement 2 groups (of 28 and 29 people) Mean age (SD): control group, 69 (± 8); experimental group, 70 (± 7) Sex: control group, 8 males and 20 females; experimental group, 3 males and 26 females |
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Interventions | Spinal anaesthesia using 2.5 mL of 5 mg/mL isobaric bupivacaine
100 mg bupivacaine (5 mg/mL, 20 mL), 5 mg morphine sulphate (5 mL), 0.6 mg epinephrine (0.6 mL), 30 mg ketorolac tromethamine (1 mL), and 73.4 mL saline (total volume: 100 mL). The first 25 mL were injected into the posterior knee capsule and soft tissue around the medial and lateral collateral ligaments before implantation. Quadriceps muscle, retinacular tissues, pes anserinus, and suprapatellar and infrapatellar fat pad, then infiltrated with the rest of the mixture. Postoperative analgesia:
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Outcomes | Primary outcomes:
Secondary outcomes:
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Funding source | Not provided | |
Declarations of interest | None reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computerized block randomization was done by an independent research assistant (TY) who otherwise was not engaged in the study. The anaesthesiologist assistant nurse, who opened sealed opaque envelopes containing the randomization result, allocated patients into each group." |
Allocation concealment (selection bias) | Low risk | "The anaesthesiologist assistant nurse, who opened sealed opaque envelopes containing the randomization result, allocated patients into each group." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Personnel was not blinded. It is unclear whether participants were blinded or aware of their group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "A clinical investigator (SK) who was not aware of the randomization
collected demographic data, preoperative clinical conditions using
predesigned data sheets, and perioperative data, and entered them in a
database." However, there is no mention of blinding of the assessor of the long‐term outcome. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two knees were excluded from analysis because one had drain dislodgement before 48 hours and the other had a periprosthetic fracture (Lewis and Rorabeck Type 2) from an accident 6 weeks after surgery." |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |