Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Dural Puncture Epidural Anesthesia; Rigid Cystoscopy
• Intervention / Treatment: Drug: hyperbaric bupivacaine and fentanyl; Drug: plain bupivacaine and fentanyl

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal Anesthesia; Patients received 3-ml hyperbaric bupivacaine 0.5% and 25 mcg fentanyl (0.5-ml).	Drug: hyperbaric bupivacaine and fentanyl; Patients received 3ml hyperbaric bupivacaine 0.5% combined with 25 microg of fentanyl.; Other Names: Spinal Anesthesia
Experimental: Dural Puncture Epidural Anesthesia; 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; 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.; Other Names: Dural Puncture Epidural Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of onset of motor block	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.	Till the end of the surgery
Incidence of side effects	Incidence of side effects such as (hypotension and bradycardia) were recorded.	24 hours postoperatively
Number of patients required rescue analgesia	Number of patients required rescue analgesia was measured.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Wounds and Injuries; Muscle Rigidity; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Anesthetics; Fentanyl; Bupivacaine
• Other Study ID Numbers: 35621/8/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No