CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

Labor Pain Clinical Trial

— SSS  

Official title:

Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117595
• Other study ID #: SAS/17/03
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: July 2018
• Source: Lagos State Health Service Commission
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Bupivacaine-fentanyl
Dosages as previously written
• Bupivacaine-fentanyl morphine
Dosage as previously written

Locations

Country	Name	City	State
Nigeria	Lagos Island Maternity Centre	Lagos

Sponsors (1)

Lead Sponsor	Collaborator
Sarah Beckley

Country where clinical trial is conducted

Nigeria, 

References & Publications (3)

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

Outcome

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