Overview
Role of the Single-shot Spinal Analgesia to Control Labour Pain
Status:
Unknown status
Unknown status
Trial end date:
2016-11-01
2016-11-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Labor pain is the most severe pain most women will endure in their lifetimes. The most complete and effective method of pain relief during childbirth is neuraxial labor analgesia which provides adequate analgesia without maternal or fetal sedation. Epidural and combined spinal-epidural (CSE) analgesia are the standard techniques performed in the developed countries. Having an epidural catheter in place produces flexibility with labor management. The catheter can be dosed intermittently for parturients in whom labor is prolonged, who require surgical manipulation for vaginal delivery, or who require cesarean section for delivery (1). However, unavailability of full-time epidural services in low-resource countries results in minimal or no analgesia provided to laboring parturients. The suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly progressing labor in primiparous and multiparous women and was found that it may be a useful alternative for painless labor in the case of limited resources for epidural analgesia (2,3,4). However, duration of action is a limiting factor of intrathecal analgesia, particularly for primiparous women. A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5 mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of analgesia. So, this dosage combination can be used at an early stage in appropriately-selected primigravida parturients. The purpose of this study is to investigate the safety and effectiveness of single-dose spinal analgesia to control labor pain in properly-selected primiparous women in a tertiary referral maternity hospitalPhase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Minia UniversityCollaborators:
Dr Haidy Salah
Dr Wegdan Ali AbdelrahmanTreatments:
Fentanyl
Criteria
Inclusion Criteria:- primigravida parturients with ASA physical status I and II, term pregnancy of
singleton fetus, all vertex presentation and uncomplicated pregnancies.
After the parturients being in active labor, dilated at least 4 to 5 cm and asking for
painless labor, they were selected by an experienced obstetrician to receive spinal
analgesia, based on obstetric parameters such as cervical dilatation and effacement and
position of the fetal head
Exclusion Criteria:
- patients with contraindications to regional anesthesia, diagnosed fetal abnormalities,
allergy to the study drugs or previous systemic opioid administration