Single Shot Intrathecal Analgesia in Vaginal Delivery

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05998551
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery

Condition or Disease	Intervention/Treatment	Phase
Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery	Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Bupivacaine Hcl 0.5% Inj	N/A

Detailed Description

Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.

In this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patientThe eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Computer generated number lists and use of sealed opaque envelopes , double blinded trial
• Primary Purpose: Treatment
• Official Title: Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine Group participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline).	Drug: Dexmedetomidine; intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine
Active Comparator: Fentanyl group participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline).	Drug: Fentanyl; intrathecal injection of fentanyl added to hyperbaric bupivacaine
Active Comparator: Control group participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline	Drug: Bupivacaine Hcl 0.5% Inj; intrathecal injection of hyperbaric bupivacaine only

Outcome Measures

Primary Outcome Measures

1. Duration of pain relief [Up to 6 hours after intrathecal injection]

   The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4

2. analgesic onset time [within 15 minutes after intrathecal injection]

   The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4

3. maximum level of sensory block [15 min after the intrathecal injection]

   Temperature will be assessed using methylated soaked swabs on both sides of the body

4. visual analogue scale (VAS) of the labour pain [6 hours after intrathecal injection]

   The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours

5. S1 regression time [6 hours after intrathecal injection]

   S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome

Secondary Outcome Measures

1. Maternal blood pressure [6 hours post operative]

   any change more than 20% of baseline mean arterial pressure

2. Maternal heart rate [6 hours post operative]

   any change more than 20% of baseline heart rate

3. Post operative nausea and vomiting [6 hours post operative]

   Number of participants having post operative nausea and vomiting

4. Post operative urinary retention [6 hours post operative]

   Number of participants having post operative urinary retention

5. Fetal heart sounds [from intrathecal injection till delivery]

   Change more than 20% of fetal heart sounds before delivery

6. Fetal APGAR score [till 5 minutes after delivery]

   APGAR score (1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 at 1 and 5 minutes after delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

• Inclusion criteria:

• Multiparous women who received antenatal care, presented for vaginal delivery of uncomplicated term pregnancy of singleton fetus with engaged fetal head and cervical dilatation of at least 5 cm requiring oxytocin augmentation, and requested analgesia.

• Age: patients between 22-45 years old.

• Exclusion criteria:

• Refusal of procedure or participation in the study.

• Patients with pre-existing or pregnancy-induced hypertension, abnormal fetal heart rate tracings, obesity, endocrinal diseases and/or diagnosed fetal abnormalities.

• Contraindication to neuraxial block.

• Allergy to any of the study drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ainshams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05998551
• Other Study ID Numbers: intra-thecal analgesia
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Agnosia; Fentanyl; Dexmedetomidine; Bupivacaine

Study Results

No Results Posted as of Aug 21, 2023