Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000608965
Ethics application status
Approved
Date submitted
9/06/2011
Date registered
14/06/2011
Date last updated
15/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Keeping parturient in the left lateral position after spinal anesthesia with plain levobupivacaine at cesarean section reduces hypotension
Scientific title
Keeping the parturients in the left lateral position for few minutes obtains dense anesthesia for the surgical site (below T10), and delayed placing to the supine position provides less dense anesthesia up to T5 to relieve the visceral part of surgical pain
Secondary ID [1] 262351 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cesarean section 268051 0
spinal anesthesia 268052 0
Hypotension 268053 0
Condition category
Condition code
Reproductive Health and Childbirth 268195 268195 0 0
Normal pregnancy
Anaesthesiology 268224 268224 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intrathecal injection was performed in the left lateral decubitus position at the L3-4 or L2-3 interspace with a 25-gauge Quincke needle. Following free flow of cerebrospinal fluid, 2.5 mL of 0.5% isobaric levobupivacaine (Chirocaine amp, Abbott, Norway) was administered over 20 seconds without barbotage. After withdrawing the spinal needle, the patients in Group L were kept in the left lateral decubitus position for 15 minutes, after which they were turned to the supine position.
Intervention code [1] 266740 0
Treatment: Drugs
Intervention code [2] 266741 0
Prevention
Intervention code [3] 266742 0
Treatment: Other
Comparator / control treatment
After withdrawing the spinal needle, the patients in Group S patients were immediately placed in the supine position.
Control group
Active

Outcomes
Primary outcome [1] 266933 0
hypotension with using clinical assessments
Timepoint [1] 266933 0
during operation
Secondary outcome [1] 276650 0
Nausea with using clinical assessments
Timepoint [1] 276650 0
during operation
Secondary outcome [2] 276651 0
vomiting with using clinical assessments
Timepoint [2] 276651 0
during operation
Secondary outcome [3] 276652 0
satisfaction with using clinical assessments
Timepoint [3] 276652 0
during operation

Eligibility
Key inclusion criteria
Healthy, full-term parturients scheduled for elective cesarean section
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hypertension, preeclampsia, hypersensitivity to relevant drugs.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3623 0
Turkey
State/province [1] 3623 0

Funding & Sponsors
Funding source category [1] 267229 0
Hospital
Name [1] 267229 0
Hospital of Gaziantep University
Country [1] 267229 0
Turkey
Primary sponsor type
Individual
Name
Levent Sahin
Address
University st. 27310 Sehitkamil Gaziantep
Country
Turkey
Secondary sponsor category [1] 266293 0
None
Name [1] 266293 0
Address [1] 266293 0
Country [1] 266293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269220 0
Ethical Committee of Gaziantep University Hospitals
Ethics committee address [1] 269220 0
Gaziantep University, University st. 27310, Sehitkamil, GAziantep
Ethics committee country [1] 269220 0
Turkey
Date submitted for ethics approval [1] 269220 0
Approval date [1] 269220 0
Ethics approval number [1] 269220 0

Summary
Brief summary
Hypotension during spinal anesthesia is one of the main concerns in cesarean delivery. We hypothesized that keeping the parturients in the left lateral position for few minutes obtains dense anesthesia for the surgical site (below T10), and delayed placing to the supine position provides less dense anesthesia up to T5 to relieve the visceral part of surgical pain. Less dense anesthesia in the upper thoracic segments results in incomplete sympathetic block and low incidence of hypotension.
Method: In this prospective study, 60 parturients undergoing cesarean section were randomized for turning to supine position just after subarachnoid injection of 2.5 mL 0.5% plain levobupivacaine in lateral position or to stay in lateral position for 15 minutes before supine positioning. Loss of pinprick sensation to T6 was accepted as adequate for cesarean section, and surgery proceeded. Characteristics of anesthesia, incidences of hypotension, bradycardia, other adverse events, and ephedrine use were assessed.
Results: Compared to the supine group, the parturients kept in lateral position for 15 minutes experienced a marked decrease in the incidence of hypotension (33.3% vs. 83.3%, P<0.001) and adverse events related to hypotension such as nausea and vomiting (16.7% vs. 57.3%, P<0.001). In addition, ephedrine consumption per hypotension case was significantly reduced in the lateral group (5.4 +/- 4.7 mg vs 8.9 +/- 5.8, p<0.001).
Conclusion: Keeping parturients in the lateral position for 15 minutes before turning to the supine position in cesarean section can provide a reliable spinal anesthesia with lower incidence and severity of hypotension and nausea/vomiting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32724 0
Address 32724 0
Country 32724 0
Phone 32724 0
Fax 32724 0
Email 32724 0
Contact person for public queries
Name 15971 0
Levent Sahin
Address 15971 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 15971 0
Turkey
Phone 15971 0
00 90 342 3606060 # 77804
Fax 15971 0
Email 15971 0
[email protected]
Contact person for scientific queries
Name 6899 0
Levent Sahin
Address 6899 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 6899 0
Turkey
Phone 6899 0
00 90 342 3606060 # 77804
Fax 6899 0
Email 6899 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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