Spinal Analgesia as Fast Track Painless Labor

NCT05271760 | Completed DMC

• 1 other identifier: REC-HSD-64-2021
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, randomized, and controlled trial was to compare the efficacy of single-shot spinal analgesia to typical conventional treatments (continuous epidural analgesia and spinal-epidural combination) in reducing labor pain, particularly in multiparous women. we will enroll in each of the three groups(S group= single-shot Spinal group), (E group= Continuous Epidural), and (C group = combined spinal-epidural) women in advanced active labor and fulfill inclusion criteria.

Conditions

Labor Pain; Pain, Postoperative; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Assessment of degree of labor pain after administration of analgesia (spinal, epidural and combined spinal-epidural

  By using Visual Analogue score (VAS score)

  6 months

Secondary Outcomes (3)

• Patient satisfaction

  6 months

• Complications of technique

  6 months

• Cost benefits

  6 months

Study Arms (3)

S group

Single-shot Spinal group

Procedure: Single-shot spinal analgesia

E group

Continuous Epidural

Procedure: Continuous epidural analgesia

C group

combined spinal-epidural

Procedure: Combined spinal-epidural analgesia

Interventions

Single-shot spinal analgesia PROCEDURE

The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml

S group

Continuous epidural analgesia PROCEDURE

Epidural analgesia is performed using a 16-gauge Tuohy epidural needle using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural space, after negative aspiration for blood or spinal fluid a test dose of 3 ml lidocaine 1.5% with epinephrine 1:200000 will be given via inserted catheter, 10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will infuse in a rate of 6 -14 ml/h.

E group

Combined spinal-epidural analgesia PROCEDURE

Epidural analgesia is performed using a combined spinal-epidural set. using a loss-of-resistance- to-saline technique, upon feeling the loss of resistance, once epidural space will be detected, 27 G Whitacre spinal needle inserted through Touhy epidural needle, intrathecal injection of 1ml of 0.5% heavy bupivacaine (5 mg) and 25 μg fentanyl, CSF barbotage will do to reach a total volume of 2 ml. Then an epidural catheter will be introduced cranially through the needle for 5 cm in the L3-L4 epidural space, after negative aspiration for blood or spinal fluid. 10 ml of 0.125 % bupivacaine and 2ug/ml fentanyl will be injected as a loading dose then the solution will infuse at a rate of 6 -14 ml/h if needed.

C group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The required sample size was n= 27 in each group (Totally of 81). Therefore, we will enroll 102 patients to account for the dropout rate of 20%.

You may qualify if:

• Multiparous parturients
• ASA physical status II,
• Full-term singleton fetus
• Vertex presentation requesting analgesia during labor.
• Active labor, 4 to 5 cm dilated cervix

You may not qualify if:

• Patients with contraindications to regional anesthesia
• Complicated pregnancies
• Primiparous parturients
• Diagnosed fetal abnormalities
• Allergy to the study medications
• INR \>1.3, and or platelets count \<100,000

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Labor Pain; Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Ahmed Abodonya, MD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: March 9, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)