Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

NCT06507397 | Completed

• 1 other identifier: 35621/8/22
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Dural Puncture Epidural Anesthesia; Spinal Anesthesia; Rigid Cystoscopy

Outcome Measures

Primary Outcomes (1)

• Assessment of the onset of anesthesia

  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.

  Every 15 minutes till end of the surgery

Secondary Outcomes (3)

• Time of onset of motor block

  Till the end of the surgery

• Incidence of side effects

  24 hours postoperatively

• Number of patients required rescue analgesia

  24 hours postoperatively

Study Arms (2)

Spinal Anesthesia

ACTIVE COMPARATOR

Patients received 3-ml hyperbaric bupivacaine 0.5% and 25 mcg fentanyl (0.5-ml).

Drug: hyperbaric bupivacaine and fentanyl

Dural Puncture Epidural Anesthesia

EXPERIMENTAL

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.

Drug: plain bupivacaine and fentanyl

Interventions

hyperbaric bupivacaine and fentanyl DRUG

Patients received 3ml hyperbaric bupivacaine 0.5% combined with 25 microg of fentanyl.

Also known as: Spinal Anesthesia

Spinal Anesthesia

plain bupivacaine and fentanyl DRUG

Patients received 15 mL mixture of (0.25% plain bupivacaine and 50 µg 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.

Also known as: Dural Puncture Epidural Anesthesia

Dural Puncture Epidural Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Fentanyl; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: October 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)