Role of the Single-shot Spinal Analgesia to Control Labour Pain

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 hospital

Conditions

• Labour Analgesia

Interventions

DRUG

"bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl "

The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the parturients were placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen was applied using nasal cannula (2-4 L/min). Routine monitoring included maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram was recorded continuously throughout the study period

Sponsors & Collaborators

• Dr Wegdan Ali Abdelrahman

  collaborator UNKNOWN

• Dr Haidy Salah

  collaborator UNKNOWN

• Minia University

  lead OTHER

Principal Investigators

• Ahmed R Abdelraheim, MD, MRCOG · Department of Obstetrics and Gynaecology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2016-10-31

Completion

2016-11-30

Countries

• Egypt

Study Locations