|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ANZCTR |
|
Last refreshed on:
|
11 June 2018 |
|
Main ID: |
ACTRN12618000643279 |
|
Date of registration:
|
23/04/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Postoperative pain after open cholecystectomy
|
|
Scientific title:
|
Postoperative pain in diabetic patients following open cholecystectomy |
|
Date of first enrolment:
|
30/06/2016 |
|
Target sample size:
|
70 |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.anzctr.org.au/ACTRN12618000643279.aspx |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Key inclusion & exclusion criteria
|
|
Health Condition(s) or Problem(s) studied
|
|
Cholelithiasis
|
|
postoperative pain
|
|
Diabetes
|
|
Intervention(s)
|
Patients without or with type 2 diabetes diagnosed with chronic cholecystitis and scheduled for elective open cholecystectomy will be studied.
All patients will receive a general anaesthetic and maintained with sevoflurane 1.5% and fentanyl 5 µg/kg. Patients also receive diclofenac 75 mg i.v. once before the surgical incision.
Haemodynamic variables were defined as: hypotension (MAP < 60 mmHg), hypertension (MAP > 100 mmHg), bradycardia (heart rate < 40 beats/min) and tachycardia (heart rate > 90 beats/min).
After completion of the surgical procedure (final suture) and emergence from anaesthesia, all patients will be transferred to the recovery room.
Duration of surgery was defined as the time from skin incision to completion of skin suturing. Onset of postoperative pain was defined as the time from end of anaesthesia until presence of any postoperative pain score. Pain management will be immediately after assessment according to institutional standards.
Postoperative pain will be evaluated by using a 0–10 numerical rating scale (NRS) (0 = no pain and 10 = worst pain imaginable), and onset of postoperative pain will be defined as the time from end of anaesthesia until presence of any postoperative pain score. Each
participants will be observed for at least 8 hours post-surgery,
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|