CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

NCT03117595 | Completed Phase 4 DMC

• 1 other identifier: SAS/17/03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Labor Pain

Keywords

Single Shot Spinal; Intrathecal narcotics; Morphine; Fentanyl; Labour Analgesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Delivery before TFA or delivery after TFA

  duration of labour estimated 180 minutes

• Maternal Satisfaction

  up to 300 minutes

• Side effects

  up to 180 minutes

Study Arms (2)

BF

ACTIVE COMPARATOR

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

BFM

ACTIVE COMPARATOR

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

Interventions

Bupivacaine-fentanyl DRUG

Dosages as previously written

BF

Bupivacaine-fentanyl morphine DRUG

Dosage as previously written

BFM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Parturients in active labour \>4cm dilatation
• American Society of Anesthesiologists (ASA) classification I and II

You may not qualify if:

• Significant co-morbidities like uncontrolled hypertension or diabetes
• Maternal hemorrhage with hypotension
• Significant bleeding/clotting disorders

Sponsors & Collaborators

• Sarah Beckley: lead

Study Sites (1)

Lagos Island Maternity Centre

Lagos, Nigeria

Location

Related Publications (3)

• 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.

  PMID: 17872679 BACKGROUND

• 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.

  PMID: 10700784 BACKGROUND

• 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.

  PMID: 12818975 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olaniyi Oladapo, MBBS,FMCA, FWACS

  School of Anaesthetic Studies, Health Service Commission, Lagos State

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: a double blinded study. The participant and the Physician giving the treatment who would also evaluate the participant during the duration of the study are masked. However, the Assistant who is in charge of the randomization process and has the code and so would prepare the drugs is not blinded. The non-blinded Assistant would be available to break the code in the event of any adverse reactions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Registrar and Diplomate, Dept of Anaesthesia, General Hospital, Gbagada Lagos, Nigeria

Model Details: 2 groups that would remain with the randomly picked intervention throughout the study duration

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 18, 2017
• Study Start: November 23, 2017
• Primary Completion: February 27, 2018
• Study Completion: April 25, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

NG (1)