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

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ClinicalTrials.gov Identifier: NCT02800694
Recruitment Status : Unknown
Verified June 2016 by Ahmed Rabie Abdelraheim, Minia University.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborators:
Dr Wegdan Ali Abdelrahman
Dr Haidy Salah
Information provided by (Responsible Party):
Ahmed Rabie Abdelraheim, Minia University

Brief 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


Condition or disease Intervention/treatment Phase
Labour Analgesia Drug: "bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl " Not Applicable

Detailed Description:

This prospective study will be conducted in El-Minia Maternity University Hospital after obtaining approval from the hospital ethical committee and informed consent from the participating parturients. The study will be conducted in the period from July to october 2016. Candidates for spinal analgesia included primigravida parturients with ASA physical status I and II, term pregnancy of singleton fetus, all vertex presentation and uncomplicated pregnancies. Excluded from the study were patients with contraindications to regional anesthesia, diagnosed fetal abnormalities, allergy to the study drugs or previous systemic opioid administration. 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.

Following monitoring with noninvasive blood pressure, electrocardiogram and pulse oximeter and recording of baseline vital signs, 18-G intravenous cannula was inserted and Ringer's solution 10 ml/kg was administered. Under strict aseptic technique, spinal analgesia was performed using pencil-point 25G spinal needle at the L3-L4 or L4-L5 interspace with the patients in the sitting position. 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of the Single-shot Spinal Analgesia to Control Labour Pain in Appropriately-selected Primiparous Parturients: A Prospective Study
Study Start Date : July 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl


Intervention Details:
  • 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


Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) for assessment of degree of labour pain after administration of spinal analgesia [ Time Frame: 6 hours after administration of spinal analgesia ]
  2. Number of participants with treatment-related adverse events [ Time Frame: Up to 24 hours after administration of spinal analgesia ]
  3. Duration of pain relief [ Time Frame: 12 hours after spinal analgesia ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800694


Contacts
Contact: Wegdan A Abdelrahman, MD 00201002522558

Locations
Egypt
Department of Obstetrics and Gynaecology, Minia University Hospital
Minia, Egypt
Sponsors and Collaborators
Minia University
Dr Wegdan Ali Abdelrahman
Dr Haidy Salah
Investigators
Principal Investigator: Ahmed R Abdelraheim, MD, MRCOG Department of Obstetrics and Gynaecology

Responsible Party: Ahmed Rabie Abdelraheim, Dr Ahmed Rabie Abdelraheim, lecturer of Obstetrics And Gynaecology, Minia University
ClinicalTrials.gov Identifier: NCT02800694     History of Changes
Other Study ID Numbers: MUH2496
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Labor Pain
Pain
Physiological Effects of Drugs
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics