Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 273
- Locations
- 2
- Primary Endpoint
- incidence of bilateral sacral blockade
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 55 Years (Adult)
- Sex
- Female
- Accepts 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).
Arms & Interventions
Conventional Epidural Technique
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.
Intervention: 25G Dural Puncture Epidural Technique (Procedure)
Conventional Epidural Technique
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.
Intervention: 27G Dural Puncture Epidural Technique (Procedure)
Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Intervention: 27G Dural Puncture Epidural Technique (Procedure)
Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Intervention: Standard Lumbar Epidural Technique (Procedure)
Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle
Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Intervention: Standard Lumbar Epidural Technique (Procedure)
Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle
Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Intervention: 25G Dural Puncture Epidural Technique (Procedure)
Outcomes
Primary Outcomes
incidence of bilateral sacral blockade
Time Frame: 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 Outcomes
- 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)
- 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 motor block(Assessed every 20 minutes after achieving Bromage 3 motor block)
- Duration of analgesia(Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively)
- Duration of sensory block(Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia)
- 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)
Investigators
Reham Ali Abdelhaleem Abdelrahman
Lecturer of Anesthesia
Cairo University