Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000391673
Ethics application status
Approved
Date submitted
29/03/2014
Date registered
10/04/2014
Date last updated
10/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative tramadol combined with diclofenac sodium reduces intraoperative loading dose of tramadol in patients undergoing abdominal hysterectomy
Scientific title
Preoperative tramadol combined with diclofenac sodium reduces intraoperative loading dose of tramadol in patients undergoing abdominal hysterectomy: A randomized trial
Secondary ID [1] 284361 0
nil
Universal Trial Number (UTN)
U1111-1152-4158
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain
 291521 0
Condition category
Condition code
Anaesthesiology 291892 291892 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
35-65 year-old, 45 ASA I and II patients, undergoing elective total abdominal hysterectomy (TAH) with or without bilateral salpingo-oopherectomy (BSO) under general anesthesia in Ankara EZH Research and Teaching Hospital, were enrolled (1:1:1) into this prospective, randomized, double-blind study. All patients received 1 mg/kg intravenous (iv) tramadol (infused in 100 ml NS over 15 minutes) and 75 mg intramuscular (im) diclofenac sodium 30 minutes before surgery. The patients were randomized into three groups (using computer-generated random numbers list with codes in sealed envelopes) to receive either placebo (Group I), 0.5 mg/kg (Group II) or 1 mg/kg (Group III) iv tramadol at the begining of the fascia closure, about 30 minutes before the end of surgery. The different doses of tramadol, prepared and labeled according to codes, were in equal volume syringes (in normal saline). Our hypothesis was ‘iv tramadol combined with im diclofenac sodium administered 30 minutes before the operation, reduces intraoperative loading dose’.
Intervention code [1] 289090 0
Treatment: Drugs
Comparator / control treatment
Group I received Placebo (intravenous saline) for intraoperative loading dose.
Control group
Placebo

Outcomes
Primary outcome [1] 291814 0
Tramadol-PCA consumption in the first 24 hours postoperatively
Timepoint [1] 291814 0
Postoperative 24 hours
Secondary outcome [1] 307601 0
Emergence time (time elapsed from the termination of anesthetic agents to gaining the ability of spontaneous eye opening, gripping fingers and breathing deeply on request)
Timepoint [1] 307601 0
Postoperative 24 hours
Secondary outcome [2] 307650 0
sedation score (alert,0; drowsy but rousable to voice,1; drowsy but rousable to shaking,2)
Timepoint [2] 307650 0
Postoperative 24 hours
Secondary outcome [3] 307651 0
postoperative nausea and vomiting
Timepoint [3] 307651 0
Postoperative 24 hours
Secondary outcome [4] 307652 0
Time to first activation of Patient Control Analgesia (PCA)(time elapsed from the administration of intraoperative loading dose)
Timepoint [4] 307652 0
Postoperative 24 hours
Secondary outcome [5] 307653 0
Verbal rating scale scores (Pain: none,0; mild,1; moderate,2; strong,3; unbearable,4)
Timepoint [5] 307653 0
Postoperative 24 hours
Secondary outcome [6] 307654 0
rescue analgesic medication
Timepoint [6] 307654 0
postoperative 24 hours

Eligibility
Key inclusion criteria
Elective Total Abdominal Hysterctomy with or without BSO under general anesthesia
Minimum age
35 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy, sensitivity or contraindications to study drugs, inability to use PCA device, long-term use of opioid medications, use of any analgesic drugs in the last 24 hours, history of clinically significant cardiac, respiratory, hepatic or renal disease and history of chronic pain and previous history of postoperative nausea and vomiting.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2011
Actual
4/07/2011
Date of last participant enrolment
Anticipated
Actual
30/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 5943 0
Turkey
State/province [1] 5943 0
Ankara

Funding & Sponsors
Funding source category [1] 289002 0
Self funded/Unfunded
Name [1] 289002 0
none
Country [1] 289002 0
Primary sponsor type
Hospital
Name
Turkish Ministery of Health Ankara Etlik ZH Maternity and Women’s Health Research and Teaching Hospital, Ankara, Turkey
Address
Asagi Eglence Mah., Yeni Etlik Cd, 06010 Etlik (Incirli)/Ankara
Country
Turkey
Secondary sponsor category [1] 287680 0
None
Name [1] 287680 0
Address [1] 287680 0
Country [1] 287680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290811 0
IRB of Turkish Ministery of Health Ankara Etlik ZH Maternity and Women’s Health Research and Teaching Hospital
Ethics committee address [1] 290811 0
IRB of Turkish Ministery of Health Ankara Etlik ZH Maternity and Women’s Health Research and Teaching Hospital, Etik Kurul Asagi Eglence Mah., Yeni Etlik Cd, 06010 Etlik (Incirli)/Ankara
Ethics committee country [1] 290811 0
Turkey
Date submitted for ethics approval [1] 290811 0
Approval date [1] 290811 0
26/04/2011
Ethics approval number [1] 290811 0

Summary
Brief summary
Intraoperative use of loading doses of tramadol-patient control analgesia (PCA) has been recommended in previously published articles. It is recommended mostly due to its diminishing effect on the frequency of postoperative nausea and vomiting (PONV) at Postanesthesia Care Unit (PACU), which is immediately after surgery. There is also a recommendation on the optimal intraoperative loading dose actually by the same authors, which is 2.5 mg.kg-1. We used this recommended optimal dose in our clinic, and we observed that emergence times of our patients prolonged to a duration of more than 40 minutes. We planned this study in order to reduce the need for intraoperative loading dose to a lower dose than 2.5 mg.kg-1. We hypothesized that preoperatively administered analgesics reduce the intraoperative loading dose. Our results revealed that this optimal dose may be reduced to a lower dose, while both providing adequate analgesia with less tramadol-PCA consumption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45766 0
Dr Filiz Uzumcugil
Address 45766 0
Hacettepe University School of Medicine Department of Anesthesiology and Reanimation 06100 Sihhiye-ANKARA
Country 45766 0
Turkey
Phone 45766 0
+903123051265
Fax 45766 0
Email 45766 0
[email protected]
Contact person for public queries
Name 45767 0
Dr Filiz Uzumcugil
Address 45767 0
Hacettepe University School of Medicine Department of Anesthesiology and Reanimation 06100 Sihhiye-ANKARA
Country 45767 0
Turkey
Phone 45767 0
+903123051265
Fax 45767 0
Email 45767 0
[email protected]
Contact person for scientific queries
Name 45768 0
Dr Filiz Uzumcugil
Address 45768 0
Hacettepe University School of Medicine Department of Anesthesiology and Reanimation 06100 Sihhiye-ANKARA
Country 45768 0
Turkey
Phone 45768 0
+903123051265
Fax 45768 0
Email 45768 0
[email protected]

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