Regional Blocks of Gynecological Surgeries

Not Applicable

Completed

• Conditions: Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia
• Interventions: Procedure: 25G Dural Puncture Epidural Technique; Procedure: Standard Lumbar Epidural Technique; Procedure: 27G Dural Puncture Epidural Technique

• Registration Number: NCT03790748
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-23
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-02
• Study Start: 2019-02-01
• Primary Completion: 2021-06-28
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 273

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Epidural Technique	27G Dural Puncture 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.
Conventional Epidural Technique	25G Dural Puncture 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.
Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle	25G Dural Puncture Epidural Technique	Procedure: 27G 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 25G Whitacre needle	Standard Lumbar Epidural Technique	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	Standard Lumbar Epidural Technique	Procedure: 27G 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 25G Whitacre needle	27G Dural Puncture Epidural Technique	Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1
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
Duration of sensory block	Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia	Time to two segmental dermatomes regression
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

Trial Locations

Locations (2)

Department of Anesthesia, Surgical ICU, and Pain Management; 🇪🇬 Cairo, Egypt

Reham Ali Abdelrahman; 🇪🇬 Cairo, Egypt