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NCT Number: NCT06507397

Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

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.

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Key information

Conditions

Dural Puncture Epidural Anesthesia Rigid Cystoscopy Spinal Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyperbaric bupivacaine and fentanyl

Drug

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

Other names: 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.

Other names: Dural Puncture Epidural Anesthesia

Primary outcomes

  1. Assessment of the onset of anesthesia

    Time frame: 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 outcomes

  1. Time of onset of motor block

    Time frame: 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.

  2. Incidence of side effects

    Time frame: 24 hours postoperatively

    Incidence of side effects such as (hypotension and bradycardia) were recorded.

  3. Number of patients required rescue analgesia

    Time frame: 24 hours postoperatively

    Number of patients required rescue analgesia was measured.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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