Clinical trial NCT03117595: CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens
Official title: Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Keywords: Single Shot Spinal
Intrathecal narcotics
Morphine
Fentanyl
Labour Analgesia
Lead sponsor: Lagos State Health Service Commission
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups that would remain with the randomly picked intervention throughout the study duration
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia.

94 multiparous parturients in active labour who have given informed consent would be recruited into the study. They would be randomly allocated into 2 groups using simple random sampling. An Assistant would know the code and prepare the intrathecal solutions.

Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off.

Routine monitoring would be done and various parameters and indices noted. Where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted.

Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20.

Eligibility criteria: 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

Primary outcomes:
measure: Time to First painless contraction (TFC)
timeFrame: time zero to first painless contraction estimated 15 minutes
measure: Time to First Request for Analgesia (TFA)
timeFrame: Time zero till NRS > 6 estimated 180 minutes
Secondary outcomes:
measure: Delivery before TFA or delivery after TFA
timeFrame: duration of labour estimated 180 minutes
measure: Maternal Satisfaction
timeFrame: up to 300 minutes
measure: Side effects
timeFrame: up to 180 minutes
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Lagos Island Maternity Centre
Study officials:
affiliation: School of Anaesthetic Studies, Health Service Commission, Lagos State
name: Olaniyi Oladapo, MBBS,FMCA, FWACS
role: STUDY_CHAIR
References:
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.
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. doi: 10.1093/bja/83.6.868.
citation: 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. doi: 10.1213/01.ane.0000066520.30763.b8.