Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Dural Puncture Epidural Anesthesia; Rigid Cystoscopy
• Interventions: Drug: hyperbaric bupivacaine and fentanyl; Drug: plain bupivacaine and fentanyl

• Registration Number: NCT06507397
• Lead Sponsor: Tanta University

Brief Summary

The main objective of this study was to determine if the dural puncture epidural (DPE) anesthesia provides superior analgesia and better patient satisfaction when compared to traditional spinal anesthesia for rigid cystoscopy.

Detailed Description

Most urologic surgeries are performed in a narrow and limited space with the minimally invasive technique or cystoscope, and most patients undergoing urologic surgeries are elderly individuals with other diseases.

Cystoscopic evaluation of the lower urinary tract is a vital part of an office-based urologic practice. However, regular surveillance cystoscopy is a significant source of morbidity for patients, and therefore attempts have been made to minimize discomfort secondary to this procedure.

Spinal anesthesia is popular for endoscopic urological surgery because of early recognition of symptoms caused by overhydration, transurethral resection of prostate (TURP) syndrome and bladder perforation.

The dural puncture epidural (DPE) technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural (EPL) technique without the side effects observed with the CSE technique.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Age ≥18 years.
• Both sex.
• American Society of Anesthesiology (ASA) physical status I, II, III.
• Admitted for elective rigid cystoscopy.

Exclusion Criteria

• Refusal of patients.
• Body Mass Index (BMI) > 35.
• Patients who have history of substance abuse.
• Patients with difficult communication.
• Contraindication to neuraxial anesthesia (e.g.; infection near the site of injection, coagulopathy or bleeding disorder).
• Patients with history of allergy to local anesthetics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Anesthesia	hyperbaric bupivacaine and fentanyl	Patients received 3-ml hyperbaric bupivacaine 0.5% and 25 mcg fentanyl (0.5-ml).
Dural Puncture Epidural Anesthesia	plain bupivacaine and fentanyl	Patients received 15-ml mixture of bupivacaine 0.25% and 50 mcg fentanyl over 5 minutes , injected in the epidural space by epidural catheter at L3-L4 interspace, a dural puncture was created by the spinal needle. Braun's Espocan® combined spinal epidural kit before insertion of epidural catheter (needle-through-needle technique) but intrathecal medication administration was withheld.

Primary Outcome Measures

Name	Time	Method
Assessment of the onset of anesthesia	Every 15 minutes till end of the surgery	Assessment of the onset by test sensory loss at T10 by pin prick using sterile needle with blunt edge (defined as time from end of injection of bolus dose to 1st sign of sensory block at T10).; Sensory level of the techniques which was assessed at 2 min after end of injection of the drug then every 5 min till the 30 min then every 15 min till end of the surgery.

Secondary Outcome Measures

Name	Time	Method
Time of onset of motor block	Till the end of the surgery	Time of onset of motor block was assessed from end of drug injection to time of achieving Breen Modified Bromage scale (BMBS) grade 1) in the lower extremities was assessed by using a BMBS: Grade 1 as complete motor block to Grade 6 as no motor block) and it was assessed at 2 min then every 3 min after injection of the drug till 30 min then every 15 min till the end of the surgery.
Incidence of side effects	24 hours postoperatively	Incidence of side effects such as (hypotension and bradycardia) were recorded.
Number of patients required rescue analgesia	24 hours postoperatively	Number of patients required rescue analgesia was measured.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt