Regional Blocks of Gynecological Surgeries

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries

Conditions
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Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia

Intervention / Treatment
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* Procedure: Standard Lumbar Epidural Technique
* Procedure: 25G Dural Puncture Epidural Technique
* Procedure: 27G Dural Puncture Epidural Technique


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Epidural Technique<br>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. | Procedure: 25G Dural Puncture Epidural Technique<br>* 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.<br>Procedure: 27G Dural Puncture Epidural Technique<br>* 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.<br>|
| Active Comparator: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle<br>Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. | Procedure: Standard Lumbar Epidural Technique<br>* Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.<br>Procedure: 27G Dural Puncture Epidural Technique<br>* 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.<br>|
| Active Comparator: Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle<br>Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. | Procedure: Standard Lumbar Epidural Technique<br>* Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.<br>Procedure: 25G Dural Puncture Epidural Technique<br>* 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease