An interventional study of Total hip replacement and Hemi-arthroplasty in Hemiarthroplasty and Arthroplasty, Replacement, Hip, sponsored by Chuncheon Sacred Heart Hospital. Completed. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Chuncheon Sacred Heart Hospital · Not applicable, Interventional, and Treatment
Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has a form that is increased in the morning and decreased in the evening. The investigators expected to be influenced by circadian rhythm according to the time of operation, and compared morning and afternoon surgery.
44 patients to undergo hip hemiarthroplasty or total hip replacement were divided to morning surgery group(Group A) and afternoon surgery group(Group P). All surgery was done by the same orthopedic surgeon. Anesthesia of Group A was started at 8 a.m. and Group P was at 12\~2 p.m. Blood sampling was performed at 7:30 a.m., after induction of anesthesia, 6, 12, 24 and 48 hours after surgery in all patients of both groups. Cortisol, IL-6, and IL-8 was measured immediately after blood sampling. Visual analogue scale(VAS) was used to assess the degree of pain at before start of anesthesia, 6, 12, 24 and 48 hours after surgery. The postoperative hospital stay was calculated. Postoperative management was done by the same management team. Surgical wounds were treated at the same 24 hour intervals.
A sample size was calculated to differentiate between groups. Because difference of cortisol according to groups in ANOVA based on pilot study, the sample size was 20 patients per group. (Effect size f(v)= 0.5297047, α=0.05, 1-β=0.90) The investigators recruited total 44 patients to cover dropout 10%.
Chuncheon Sacred Heart Hospital is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the morning
Procedure: Total hip replacement · Procedure: Hemi-arthroplasty
Group to begin surgery(total hip replacement or hip hemi-arthroplasty) in the afternoon
Procedure: Total hip replacement · Procedure: Hemi-arthroplasty
Total hip replacement starts in the morning in group A and starts in the afternoon in group P.
Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.
Cortisol level
Cortisol levels over time
Time frame: within the first 2 days after surgery
Interleukin-6
Interleukin-6 levels over time
Time frame: within the first 2 days after surgery
Interleukin-8
Interleukin-8 levels over time
Time frame: within the first 2 days after surgery
Visual analogue scale
pain scale over time
Time frame: within the first 2 days after surgery
Post-operative hospital stay
Hospital day after surgery.
Time frame: Hospital day after surgery.
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Chuncheon Sacred Heart Hospital