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Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

T

Tanta University

Status

Completed

Conditions

Spinal Anesthesia
Rigid Cystoscopy
Dural Puncture Epidural Anesthesia

Treatments

Drug: plain bupivacaine and fentanyl
Drug: hyperbaric bupivacaine and fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT06507397
35621/8/22

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

76 participants in 2 patient groups

Spinal Anesthesia
Active Comparator group
Description:
Patients received 3-ml hyperbaric bupivacaine 0.5% and 25 mcg fentanyl (0.5-ml).
Treatment:
Drug: hyperbaric bupivacaine and fentanyl
Dural Puncture Epidural Anesthesia
Experimental group
Description:
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.
Treatment:
Drug: plain bupivacaine and fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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