Clinical trial NCT03790748: Regional Blocks of Gynecological Surgeries
Official title: Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia
Keywords: Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 273
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: incidence of bilateral sacral blockade
timeFrame: Up to 30 minutes after local anesthetic injection
Secondary outcomes:
measure: Onset of sensory blockade
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Maximum achieved sensory level
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Time to achieve the maximum sensory level
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Onset of motor blockade
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Time to complete motor block
timeFrame: Up to 30 minutes after local anesthetic injection
measure: Duration of sensory block
timeFrame: Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
measure: Duration of motor block
timeFrame: Assessed every 20 minutes after achieving Bromage 3 motor block
measure: Duration of analgesia
timeFrame: Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
measure: Number of epidural top-ups
timeFrame: Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
measure: Sedation score
timeFrame: Assessed every 20 minutes during the surgical procedure and postoperatively
measure: Hemodynamic parameters
timeFrame: Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
measure: Perioperative side effects
timeFrame: During surgical period up to 7 days post-operatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia, Surgical ICU, and Pain Management
city: Cairo
country: Egypt
facility: Reham Ali Abdelrahman
Study officials:
affiliation: Cairo University
name: Reham Ali Abdelrahman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: