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Trial registered on ANZCTR


Registration number
ACTRN12617001372370
Ethics application status
Approved
Date submitted
27/05/2017
Date registered
27/09/2017
Date last updated
27/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the effect of intrathecal bupivacaine combined with opioids on postoperative analgesia in patients undergoing cesarean section
Scientific title
Assessment of the effect of intrathecal bupivacaine combined with opioids (morphine, fentanyl) on postoperative analgesia in patients undergoing cesarean section
Secondary ID [1] 291186 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative analgesia 302075 0
Condition category
Condition code
Reproductive Health and Childbirth 301706 301706 0 0
Childbirth and postnatal care
Surgery 302883 302883 0 0
Other surgery
Anaesthesiology 303812 303812 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients ' demographic data were recorded. Patients distributed to groups with closed envelope technique. The patients divided into three groups.
according to the administered opioids that they receive:

Group II: 8 mg 5% hyperbaric bupivacaine + 20 mcg fentanyl + 50 mcg morphine were administrated intrathecal prior to caesarean procedure by anaesthesiologist
Group III: 8 mg 5% hyperbaric bupivacaine + 20 mcg fentanyl + 100 mcg morphine were administrated intrathecal prior to caesarean procedure by anaesthesiologist

The effectiveness of spinal anesthesia was assessed with the hot-cold sensation test and Bromage scale. The surgery was initiated when the sensorial block level reaches T4 dermatome. Intraoperative pain was monitored using the Visual Analog Scale (VAS). The duration of effective analgesia till the first postoperative analgesic requirements, The additional analgesic requirement within the first 24- hours after the surgery, the amount of additional analgesics, and side effects (nausea, vomiting, pruritus, and headache) were evaluated and recorded.
Intervention code [1] 297187 0
Treatment: Drugs
Comparator / control treatment
Group I: 8 mg 5% hyperbaric bupivacaine + 20 mcg Fentanyl were administrated intrathecal prior to caesarean procedure
Control group
Active

Outcomes
Primary outcome [1] 301099 0
time of first analgesic requirement
this information is taken from patients themselves
Timepoint [1] 301099 0
24 hours post surgery
Secondary outcome [1] 331728 0
Adverse effects (itching, allergies, nausea, vomiting, urinary retention, constipation, respiratory depression, bradycardia, hypotension, dizziness i.e.)
Timepoint [1] 331728 0
during intraoperative process and 24 hours post surgery

Adverse events were recorded. If adverse events were recognized, They were evaluated according to Common Terminology Criteria for Adverse Events (CTC-AE) ver. 4.0.
This adverse events listed are assessed as recorded by treating clinician in the medical records

Eligibility
Key inclusion criteria
- 18 years older
-cesarean section under spinal anesthesia
- who know Turkish and are cooperative
- whose physical status is consistent with ASA II class
-gestational age must be >27 weeks
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-neurological disease
-preeclampsia, diabetes mellitus, infection on the surgical site,
-disorders associated with bleeding/ clotting, severe agitation,
-non-cooperation, rejection of regional anesthesia,
-obesity (body mass index >35 kg/m2),
-height shorter:150 cm,
- known fetal abnormality, placenta previa, history of ablatio placentae, risk for growth retardation and meconium aspiration; pathology that may affect the acid-base balance, antepartum hemorrhage,
-Rh incompatibility
- hypersensitivity to local anesthetics
-history of frequent analgesic use
- allergy to any medicine in the projected study protocol.

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
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
1110
Accrual to date
Final
1090
Recruitment outside Australia
Country [1] 8662 0
Turkey
State/province [1] 8662 0
bursa

Funding & Sponsors
Funding source category [1] 295628 0
Self funded/Unfunded
Name [1] 295628 0
mine akoz
Country [1] 295628 0
Turkey
Funding source category [2] 295629 0
Self funded/Unfunded
Name [2] 295629 0
derya karasu
Country [2] 295629 0
Turkey
Primary sponsor type
Individual
Name
derya karasu
Address
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country
Turkey
Secondary sponsor category [1] 294470 0
Individual
Name [1] 294470 0
canan yilmaz
Address [1] 294470 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country [1] 294470 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296947 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinical Researc Ethics Committee
Ethics committee address [1] 296947 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Ethics committee country [1] 296947 0
Turkey
Date submitted for ethics approval [1] 296947 0
16/03/2016
Approval date [1] 296947 0
30/03/2016
Ethics approval number [1] 296947 0
2011-KAEK-25 2016/06-02

Summary
Brief summary
Purpose: Our prospective, randomized, double-blind study aimed to detect the effect of intrathecal bupivacaine combined with opioids on the postoperative analgesia in patients undergoing cesarean section.
Material and Methods: 1110 patients with gestational age over 37 weeks, over 18 years of age and who undergoing elective cesarean section with spinal anesthesia were into the following three groups according to intrathecal opioids: Group 1: 8 mg 5% hyperbaric bupivacaine and 20 mcg fentanyl, Group 2: 8 mg 5% hyperbaric bupivacaine and 20 mcg fentanyl + 50 mcg morphine, Group 3: 8 mg 5% hyperbaric bupivacaine and 20 mcg fentanyl + 100 mcg morphine. First analgesic requirement time, intraoperative and postoperative side effects, intraoperative visual analog scale (VAS) were recorded.
Results: 1090 patients were included in the statistical evaluation. Intraoperative nausea and vomiting were significantly less in the Group 3 (p=0.047). Intraoperative pruritus was significantly higher in Group 3 compared to the other two groups (p<0.001). There was no difference between the groups in terms of intraoperative VAS values. Postoperative nausea, vomiting, pruritus, hypotension, bradycardia were similar among the groups. Patient satisfaction was lowest in Group 1 and highest in Group 3 (p<0.001). The duration of first analgesia was short in Group 1 (p<0.001).
Conclusions: We concluded that, morphine added to bupivacaine and fentanyl for spinal anesthesia increased the duration of the first analgesic requirement and that 50 and 100 mcg of morphine were not superior to each other in terms of side effects and first analgesic duration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72510 0
Dr mine aköz
Address 72510 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 72510 0
Turkey
Phone 72510 0
+905077069100
Fax 72510 0
Email 72510 0
[email protected]
Contact person for public queries
Name 72511 0
derya karasu
Address 72511 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 72511 0
Turkey
Phone 72511 0
+905057281175
Fax 72511 0
Email 72511 0
[email protected]
Contact person for scientific queries
Name 72512 0
canan yilmaz
Address 72512 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 72512 0
Turkey
Phone 72512 0
+905059045989
Fax 72512 0
Email 72512 0
[email protected]

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