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Labor PainNCT05271760

Spinal Analgesia as Fast Track Painless Labor

An observational study of Labor Pain and Pain, Postoperative, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain, Pain, Postoperative, Pain, Acute
What is being tested?
Single-shot spinal analgesia, Continuous epidural analgesia and Combined spinal-epidural analgesia
How many people
102 participants
Where
1 siteSaudi Arabia
Study dates
1 Mar 2022to 1 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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%.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Prince Sattam bin Abdulaziz University

    Al Kharj, Riyadh Region, 11942

Other trials in Saudi Arabia

About this study

Official title: Fast Track Painless Labor: New Approaches for Pain-free Delivery in Multiparous Women

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.

Read the detailed description

Patients in active labor with cervical dilation between 4-5 cm multiparous with normal fetal heart rate (FHR) tracings were considered. After the request for analgesia, each patient was randomized, using a computer-generated randomization table, to receive spinal analgesia, continuous epidural analgesia, or combined spinal-epidural analgesia. Under A complete aseptic condition in a sitting position, all techniques are performed in the Labor and delivery room. All parturients are categorized into three groups as follows:

Group S (spinal n=40) 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. Group E (continuous Epidural n=40): 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.

Group C (Combined spinal-epidural n=40) 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.

Then, the parturients will be 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 will be applied using a nasal cannula (2-4 L/min).

Each patient will receive at least 10 mL/kg Ringer lactate solution. All patients will be monitored before the procedures and every 5 minutes after for 30 for any hemodynamic instability and fetal viability The duration of analgesia is defined as the time from the injection of the local anesthetic solution until the patient requested an additional analgesic dose.

After the administration of the anesthetic solution, each patient will be evaluated by an investigator every 5 min for the first 15 min. Patients are assessed every 15 min until additional analgesia is requested.

Patient appraisal included Assessment of vital signs (blood pressure, heart rate, respiratory rate) and completion by the patient of a 10-cm linear visual analog scale (VAS) for pain (0= no pain; 10 = severe pain). Patients will be excluded from the final data analysis if the patients reported pain VAS >8 up to 15 min after the injection of the anesthetic solution. At the same time intervals, somnolence will be evaluated using a four-point ordinal scale in which 0= wide awake, 1= drowsy, 2= arousable, 3 = non-arousable, the Motor blockade will be assessed using the four-point Bromage scale. The upper level of loss of sensation to ice will be assessed in the mid-clavicular line 15 min after the injection of the anesthetic solution. Time 2 segment regressions will be assessed. Side effects such as Pruritus, nausea, or vomiting Patient and obstetrician satisfaction. All patients have continuous electronic FHR monitoring throughout labor. Any FHR abnormalities, identified by the obstetric team, will be documented. After labor, the baby will be assessed, and the mother will be nursed in a post-anesthetic care unit (PACU ) and observed if there is nausea, vomiting, dyspnea, hemodynamic changes (hypotension and reflex tachycardia), and Spo2 changes will be recorded too, also patient will be evaluated for any Sensory or motor complication. The purpose of this study is to investigate the safety and effectiveness of single-dose spinal or epidural analgesia to control labor pain in properly-selected multiparous women in a tertiary referral maternity hospital.

Being tested
Single-shot spinal analgesia, Continuous epidural analgesia, Combined spinal-epidural analgesia
Medical subject headings
Labor Pain, Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single-shot spinal analgesiaProcedure or surgery

    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

  • Continuous epidural analgesiaProcedure or surgery

    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.

  • Combined spinal-epidural analgesiaProcedure or surgery

    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.

Study groups in NCT05271760
Study groupRoleWhat they receive
S groupSingle-shot Spinal group
Receives: Procedure: Single-shot spinal analgesia
E groupContinuous Epidural
Receives: Procedure: Continuous epidural analgesia
C groupcombined spinal-epidural
Receives: Procedure: Combined spinal-epidural analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    By using Visual Analogue score (VAS score)

    Measured: 6 months

Secondary outcomes (3)
  1. Patient satisfaction

    By patient satisfaction survey

    Measured: 6 months

  2. Complications of technique

    Incidence or frequency of any complication that may occur

    Measured: 6 months

  3. Cost benefits

    Cost of techniques(how much the cost of spinal kits in relation to the cost of epidural and combined spinal epidural kits in Saudi Riyal

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Apr 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271760
Sponsor's protocol ID
REC-HSD-64-2021
Status last verified
Mar 2023
First submitted
8 Dec 2021
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Labor Pain and Pain, Postoperative, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of degree of labor pain after administration of analgesia (spinal, epidural and combined spinal-epidural (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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