Health TrialsbyHealthPanel

Effect of Epidural Needle Injection on Catheter Placement Success During Painless Labour

ConditionLabour Analgesia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAl-Azhar University

About this trial

Epidural analgesia is the gold standard for painless labour, but successful catheter placement can be technically challenging due to anatomical and physiological changes in pregnancy. Injecting saline or local anesthetic through the epidural needle before catheter insertion has been proposed to facilitate catheter advancement by dilating the epidural space. This study aimed to evaluate the effect of epidural needle injection on the success rate and ease of catheter placement during labour analgesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-40 years.

ASA physical status II or III.

Singleton pregnancy.

Gestational age ≥37 weeks.

Disqualifiers

• Refusal to participate or to sign informed consent.

Age <18 or >40 years.

ASA status ≥IV.

Allergy to local anesthetics or saline.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injection Group

    Procedure/Surgery

    Patients will receive \[10 ml of local anesthetic\] through an epidural needle before catheter advancement.

  • Control group

    Other intervention

    No injection before catheter insertion.

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Injection groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Success of epidural catheterization on the first attempt.

The incidence of success of epidural catheterization on the first attempt will be determined. This measures whether the epidural catheter is successfully inserted on the first attempt after loss of resistance, without the need for repositioning or reattempt. Success is defined by obtaining adequate analgesia with proper catheter function (confirmed by clinical effect).

Time frame
Assessed immediately during the procedure at the time of epidural catheter placement.

Secondary outcomes

1

Number of catheterization attempts

Counts the total number of insertion attempts required to achieve correct epidural catheter placement, reflecting technical ease and procedural efficiency.

Time frame
Assessed during the procedure until successful catheterization is achieved.
2

Procedure duration

Measures the time elapsed between needle insertion and successful catheter placement, expressed in minutes. Shorter duration indicates greater ease of insertion.

Time frame
Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation.
3

Incidence of numbness

Records any occurrence of unexpected or abnormal sensory numbness following the epidural test dose or analgesic administration, which may indicate uneven drug spread or misplaced catheter.

Time frame
Assessed post-catheter insertion, within the first 30 minutes after drug administration.
4

Incidence of unintended dural puncture

Identifies accidental dural puncture events occurring during epidural space entry or catheter advancement.

Time frame
Assessed immediately at the time of needle insertion or catheter placement.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Benha University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: