CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens (SSS)

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

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

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Bupivacaine-fentanyl; Drug: Bupivacaine-fentanyl morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nigeria
  • Lagos, Nigeria
    • Lagos Island Maternity Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BF; Interventions: Intrathecal administration -Bupivacaine 2.5mg (0.5ml) + Fentanyl 25mcg (0.5ml) + 1ml sterile water in one shot Ephedrine 3-5mg in aliquots in the event of hypotension Promethazine 12.5 - 25mg in the event of vomiting or significant pruritus naloxone 2mcg/kg in the event of respiratory distress	Drug: Bupivacaine-fentanyl; Dosages as previously written
Active Comparator: BFM; Interventions: Intrathecal administration - Bupivacaine 2.5mg (0.5ml) + fentanyl 25mcg (0.5ml) + 0.25mg morphine (0.25ml) + 0.75ml sterile water in one shot ephedrine 3-5mg in aliquots for hypotension Promethazine 12.5 - 25mg for vomiting or significant pruritus Naloxone 2mcg/kg in the event of respiratory distress	Drug: Bupivacaine-fentanyl morphine; Dosage as previously written

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maternal Satisfaction	Parturients perception of if analgesia was Adequate, Inadequate or Not Sure	up to 300 minutes
Side effects	Presence of side effects like respiratory depression, pruritus, or vomiting	up to 180 minutes

Collaborators and Investigators

• Sponsor: Sarah Beckley
• Investigators: Study Chair: Olaniyi Oladapo, MBBS,FMCA, FWACS, School of Anaesthetic Studies, Health Service Commission, Lagos State

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): February 27, 2018
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Morphine; Fentanyl; Labour Analgesia; Single Shot Spinal; Intrathecal narcotics
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Morphine
• Other Study ID Numbers: SAS/17/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No