Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia
Conditions
Keywords
Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease
Brief summary
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.
Interventions
PROCEDUREStandard Lumbar Epidural Technique
Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
PROCEDURE27G Dural Puncture Epidural Technique
27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA I and II * Height(150-170 cm)
Exclusion criteria
* patient refusal * hypersensitivity to local anesthetic drugs * bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of bilateral sacral blockade | Up to 30 minutes after local anesthetic injection | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum achieved sensory level | Up to 30 minutes after local anesthetic injection | — |
| 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 | Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia | Time to two segmental dermatomes regression |
| Onset of sensory blockade | Up to 30 minutes after local anesthetic injection | — |
| Duration of analgesia | Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively | Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished |
| 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 | — |
| Duration of motor block | Assessed every 20 minutes after achieving Bromage 3 motor block | Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1 |
Countries
Egypt
Outcome results
None listed