Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Epidural Technique | Experimental | Procedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. |
|
| Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle | Active Comparator | Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. |
|
| Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle | Active Comparator | Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Lumbar Epidural Technique | Procedure | Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of bilateral sacral blockade | Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes) | Up to 30 minutes after local anesthetic injection |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory blockade | Up to 30 minutes after local anesthetic injection | |
| Maximum achieved sensory level | Up to 30 minutes after local anesthetic injection | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reham Ali Abdelrahman, M.D. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Surgical ICU, and Pain Management | Cairo | 11562 | Egypt | |||
| Reham Ali Abdelrahman |
Not provided
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 25G Dural Puncture Epidural Technique | Procedure | 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl. |
|
| 27G Dural Puncture Epidural Technique | Procedure | 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl. |
|
| Time to achieve the maximum sensory level |
| Up to 30 minutes after local anesthetic injection |
| Onset of motor blockade | Up to 30 minutes after local anesthetic injection |
| Time to complete motor block | Up to 30 minutes after local anesthetic injection |
| Duration of sensory block | Time to two segmental dermatomes regression | Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia |
| Duration of motor block | Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1 | Assessed every 20 minutes after achieving Bromage 3 motor block |
| Duration of analgesia | Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished | Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively |
| Number of epidural top-ups | Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery |
| Sedation score | Assessed every 20 minutes during the surgical procedure and postoperatively |
| Hemodynamic parameters | Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms |
| Perioperative side effects | During surgical period up to 7 days post-operatively |
| Cairo |
| 11562 |
| Egypt |