Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy

NCT ID: NCT06507397

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-03-01

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.

Conditions

Dural Puncture Epidural Anesthesia; Spinal Anesthesia; Rigid Cystoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Spinal Anesthesia

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

Group Type: ACTIVE_COMPARATOR

hyperbaric bupivacaine and fentanyl

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

plain bupivacaine and fentanyl

Intervention Type: 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.

Interventions

hyperbaric bupivacaine and fentanyl

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Spinal Anesthesia; Dural Puncture Epidural Anesthesia

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rabab Mohamed Mohamed Mohamed

Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

35621/8/22

Identifier Type: -

Identifier Source: org_study_id