Home » Trials » SLCTR/2015/009
Comparison of the effectiveness of intrathecal fentanyl or morphine as an adjunct on quality of anesthesia and post-operative pain relief in healthy pregnant women undergoing elective cesarean sections.
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SLCTR Registration Number
SLCTR/2015/009
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Comparison of the effectiveness of intrathecal fentanyl or morphine as an adjunct on quality of anesthesia and post-operative pain relief in healthy pregnant women undergoing elective cesarean sections.
Public Title of Trial
Comparison of the effectiveness of intrathecal fentanyl or morphine as an adjunct on quality of anesthesia and post-operative pain relief in healthy pregnant women undergoing elective cesarean sections.
Disease or Health Condition(s) Studied
Anesthesia in pregnancy
Scientific Acronym
None
Public Acronym
None
Brief title
Comparison of the effectiveness of intrathecal fentanyl or morphine as an adjunct on quality of anesthesia and post-operative pain relief in healthy pregnant mothers undergoing elective cesarean sections.
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/13-043 (Sri lanka Medical Association)
What is the research question being addressed?
Is 10 micrograms of intrathecal fentanyl more effective than 0.2 mg of intrathecal morphine when used as an adjunct on, quality of anesthesia and post operative pain relief in healthy pregnant women undergoing elective cesarean sections?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Dose comparison
Assignment
Other
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The study will be conducted at the Base Hospital Homagama, Sri Lanka. Consenting pregnant women awaiting elective ceasarian section, who fulfil the inclusion criteria will be recruited.
Patients will be randomized for the treatment of Fentanyl or Morphine as adjuvant drugs in spinal anaesthesia by throwing a dice (e.g., below and equal to 3 - fentanyl, over 3 - morphine). The randomisation will be done by one anaesthetic medical Officer and the spinal anaesthesia will be performed by another anaesthetic medical officer.
Intrathecal fentanyl 10mcg or morphine 0.2mg as an adjunct will be given with the subarachnoid blockade
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Time to first analgesic requirement |
[ Time taken after closure of the skin incision and patient requesting pain relief. (Taken as Visual analogue Scale 3) ] |
|
2.
Onset of anaesthesia (sensory block) up to T4 and onset of motor block as assessed according to the criteria of Bromage scale 3 or 4. |
[ Onset of Anaesthesia to cold sensation and pinprick. Time taken from the infiltration of drugs to subarachnoid space ] |
|
3.
Assessment of pain by visual analogue scale |
[ Before and after Anesthesia. ] |
Secondary outcome(s)
|
1.
Incidence of sedation, nausea and vomiting, pruritus, respiratory depression, and urinary retention |
[ Every 3 minutes for the 1st 15 minutes and then every 5 minutes until the patient dispatched from the theater and sent to the ward. ] |
|
2.
Maternal heart rate, respiratory rate, SPo2, non invasive blood pressure. |
[ Every 3 minutes for the 1st 15 minutes and then every 5 minutes until the patient dispatched from the theater and sent to the ward. In ward every 15 minutes for 1 hour, then every half an hour for 1 hour, then hourly for 4 hrs, then 2 hourly for 6 hrs, then 4 hourly until completion of 24 hrs. ] |
|
3.
APGAR score of the neonate |
[ At first minute, 5 minutes and 10 minutes. ] |
Target number/sample size
160 (80 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-04-14
Anticipated end date
2015-06-16
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2015-02-20
Approval number
ERC/13-043
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Juliyange Dinithi Yogya Silva
Medical Doctor
Base Hospital, Homagama
Tel: 0112855200- operating theatre
Mob: 0718217508
dinithiyogya@gmail.com
Contact Person for Public Queries
Dr Z.M.Ruhulla
Consultatant Anesthetist
Base Hospital, Homagama
Mob: 0777345042
roohullahz@hotmail.com
Primary study sponsor/organization
Base Hospital, Homagama
Homagama, Sri Lanka
Tel: 01128555200, 0115059646
http://homagamahospital.org/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
