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| Name | Class |
|---|---|
| Benha University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection group | Experimental | Patients will receive [10 ml of local anaesthetic] through an epidural needle before catheter advancement. |
|
| Control group | Placebo Comparator | No injection before catheter insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection Group | Procedure | Patients will receive [10 ml of local anesthetic] through an epidural needle before catheter advancement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessed immediately during the procedure at the time of epidural catheter placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of catheterization attempts | Counts the total number of insertion attempts required to achieve correct epidural catheter placement, reflecting technical ease and procedural efficiency. | Assessed during the procedure until successful catheterization is achieved. |
| Procedure duration |
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Inclusion Criteria:
Exclusion Criteria:
• Refusal to participate or to sign informed consent.
Painless Labour
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neveen A Kohaf, Ph.D | Contact | +201060383012 | nevenabdo@azhar.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University | Cairo | Egypt | 11865 | Egypt |
Data can be shared upon reasonable request from the corresponding author
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | No injection before catheter insertion. |
|
Measures the time elapsed between needle insertion and successful catheter placement, expressed in minutes. Shorter duration indicates greater ease of insertion. |
| Assessed intraoperatively, recorded from the beginning of the puncture until catheter fixation. |
| 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. | Assessed post-catheter insertion, within the first 30 minutes after drug administration. |
| Incidence of unintended dural puncture | Identifies accidental dural puncture events occurring during epidural space entry or catheter advancement. | Assessed immediately at the time of needle insertion or catheter placement. |
| Maternal satisfaction | Evaluates the mother's satisfaction regarding the analgesia quality, comfort during the procedure, and overall experience. Typically rated using a structured satisfaction scale. Maternal satisfaction can be measured on a 0-5 scale using a simple 5-point Likert-type item: 0 = completely dissatisfied, 1 = dissatisfied, 2 = neutral, 3 = satisfied, and 4 = very satisfied. | Assessed post-delivery, usually within 24 hours after labour. |
| D008722 | Methods |