Labor Pain Clinical Trial
— SSSOfficial title:
Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal
Verified date | July 2018 |
Source | Lagos State Health Service Commission |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall
cost of Epidural services in terms of human personnel and financial implication makes this
inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier
option that can produce as much satisfaction for the parturient and would allow her
participate in the second stage of labour by being able to bare down is being studied.
The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back
is its time limitation as the option of a top up is not available.
Two regimen of drug options would be considered using opioids. These would be compared to see
how well they are able to provide analgesia in women who hitherto have had vaginal birth.
Their onset, duration of action and possible side effects would be compared.
NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a
statistically significant difference in labour analgesia in comparison with Bupivacaine
Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a
statistically significant difference in labour in comparison with BFM
Status | Completed |
Enrollment | 100 |
Est. completion date | April 25, 2018 |
Est. primary completion date | February 27, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Parturients in active labour >4cm dilatation - American Society of Anesthesiologists (ASA) classification I and II Exclusion Criteria: - Significant co-morbidities like uncontrolled hypertension or diabetes - Maternal hemorrhage with hypotension - Significant bleeding/clotting disorders |
Country | Name | City | State |
---|---|---|---|
Nigeria | Lagos Island Maternity Centre | Lagos |
Lead Sponsor | Collaborator |
---|---|
Sarah Beckley |
Nigeria,
Hess PE, Vasudevan A, Snowman C, Pratt SD. Small dose bupivacaine-fentanyl spinal analgesia combined with morphine for labor. Anesth Analg. 2003 Jul;97(1):247-52, table of contents. — View Citation
Lee BB, Ngan Kee WD, Hung VY, Wong EL. Combined spinal-epidural analgesia in labour: comparison of two doses of intrathecal bupivacaine with fentanyl. Br J Anaesth. 1999 Dec;83(6):868-71. — View Citation
Minty RG, Kelly L, Minty A, Hammett DC. Single-dose intrathecal analgesia to control labour pain: is it a useful alternative to epidural analgesia? Can Fam Physician. 2007 Mar;53(3):437-42. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to First painless contraction (TFC) | This is the onset of action of the drugs. The time duration from the initiation of the block at time zero to the point where there is significant drop in the Numerical Rating Scale (NRS) to 2 or less | time zero to first painless contraction estimated 15 minutes | |
Primary | Time to First Request for Analgesia (TFA) | This is the duration of action of the block. Time from initiation of the block to time the pain score is up to 6 or more. It is expected that after onset of the block (TFC) the pain would first become negligible or absent and after a period of time, it would gradually increase as the drug wears off. If the pain becomes moderate at a NRS of 6 or the patient requests for analgesia, the time would be noted and the epidural would be activated. | Time zero till NRS > 6 estimated 180 minutes | |
Secondary | Delivery before TFA or delivery after TFA | Qualitative variable. determines if rescue analgesia was needed (if the epidural needed to be activated) or if the spinal was adequate for the duration of labour | duration of labour estimated 180 minutes | |
Secondary | Maternal Satisfaction | Parturients perception of if analgesia was Adequate, Inadequate or Not Sure | up to 300 minutes | |
Secondary | Side effects | Presence of side effects like respiratory depression, pruritus, or vomiting | up to 180 minutes |
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