Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001115729
Ethics application status
Approved
Date submitted
10/06/2013
Date registered
4/10/2013
Date last updated
4/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The comparison of the efficiency of Saddle Block and Caudal Anesthesia in postoperative analgesic consumption and patient comfort using levobupivacaine in patients undergoing transurethral prostate resection (TURP).
Scientific title
Saddle Block is more Advantageous than Caudal Block in Patients Undergoing Transurethral Prostate Resection
Secondary ID [1] 282647 0
No
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transurethral Prostate Resection (TURP)
 289348 0
The efficiency of Saddle Block and Caudal Anesthesia
 290232 0
Postoperative analgesic consumption 290233 0
Condition category
Condition code
Anaesthesiology 289685 289685 0 0
Anaesthetics
Anaesthesiology 290613 290613 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fifty adult male patients who were planned to undergo a transurethral prostate resection (TURP) under regional anesthesia due to benign prostate hypertrophy were included in the study with informed consent obtained from each patient. This is a prospective, randomized, and double-blind study including cases with Caudal Block (group C) or Saddle Block (GroupS) for TURP.
Group S 5% 10 mg levobupivacaine and 25micrograms fentanyl were administered to the subarachnoid space by L4-5 interspace once only for the Saddle Block. The patient was held in the sitting position with the aid of an assistant for 5-7 minutes to allow the Saddle Block to develop.
Intervention code [1] 287314 0
Treatment: Drugs
Comparator / control treatment
In caudal anesthesia group (Group C, n=25), patients were turned into a left lateral decubitus position with knees pulled up to the abdomen at 90 degrees. Following the identification of sacral corns and sacral hiatus, the site of injection was infiltrated with 2 ml of 1% lidocaine. A 7 cm long 25 G needle was introduced at an angle of 45 degrees at the vertical axis to the skin, sacrococcygeal membrane was penetrated and typically was felt that it entered a space, then the needle position was brought to a 30 degree angle to the skin and was advanced to the epidural space for 4-5 cm. After no blood was seen with aspiration, 14 ml 0.5% levobupivacaine and 25 micrograms fentanyl were injected into the epidural space in a rate of 0.5 ml/sec. The patients were placed in a neutral supine position. The patient was made to wait until a block at the T10 level was obtained. Before placing the patients into a lithotomy position, sensorial block levels were evaluated with a pinprick test. Motor block was evaluated with the Bromage scale. All these anesthetics were administered to sacral epidural space (Caudal space) once only.
Control group
Active

Outcomes
Primary outcome [1] 289772 0
Total requirement of analgesics in the first 24 hours of the postoperative period comparison between patients administered with a Saddle Block and patients administered with Caudal Anaesthesia
Timepoint [1] 289772 0
Motor block was evaluated bromage scale after just we performed the block and at 1, 3, 5, 7, 10, 15, and 20 minutes after the block was performed Mean arterial pressure (MAP), heart rate (HR), and levels of oxygen saturation (SPO2) were recorded in every 5 minutes in the preoperative, intraoperative and early postoperative periods. Patient satisfaction was evaluated using a scale in which the patients responded to the question. comfort score, age, body mass index, and duration of the operation were recorded. After the operation finished the satisfaction scores of patients were evaluated.
Secondary outcome [1] 303214 0
the efficacy of Saddle Block and Caudal Block on the patient comfort and postoperative analgesic consumption
Timepoint [1] 303214 0
first need of analgesic drugs and the amount of analgesics consumed in the first 24 hours were recorded. Patients were followed-up on for side effects during the time period until the sensorial blockage effects of the regional anesthesia faded such as hypotension (MAP<60 mmHg), bradycardia (HR<50/min), nausea, vomiting, irritability and shivering, headache, back pain, leg pain, weakness, and urinary and fecal incontinence until discharge from the hospital

Eligibility
Key inclusion criteria
50 adult male patients who were planned to undergo a transurethral prostate resection (TURP) under regional anesthesia
Minimum age
45 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who rejected regional anesthesia, who had a neurological deficit, local or systemic infection, a past medical history of allergy to local anesthetics, coagulopathy, a high intracranial pressure, severe cardiac disease, who were on NSAID, acetylsalicylic acid, oral anticoagulants, heparin, LMWH, and inhibitors of thrombocyte aggregation, or who were hypovolemic and had an inadequate block after the application were excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
The result of power analysis performed according to the total analgesic requirements in postoperative 24-hours period.
Total sample size: 40, alpha: 0.05, Actual Power: 0.95Power: 0.95, Delta: 3.41, Critical t(38)=1.68, Effect size: 1.079.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2011
Actual
3/03/2011
Date of last participant enrolment
Anticipated
3/10/2011
Actual
27/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5137 0
Turkey
State/province [1] 5137 0

Funding & Sponsors
Funding source category [1] 287583 0
University
Name [1] 287583 0
Gaziantep University
Country [1] 287583 0
Turkey
Primary sponsor type
University
Name
Gaziantep University
Address
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey, Gaziantep
Country
Turkey
Secondary sponsor category [1] 286331 0
None
Name [1] 286331 0
Address [1] 286331 0
Country [1] 286331 0
Turkey

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40650 0
Dr Ayse Mizrak
Address 40650 0
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Gaziantep, TURKEY
Country 40650 0
Turkey
Phone 40650 0
+903423606060
Fax 40650 0
+903423602938
Email 40650 0
[email protected]
Contact person for public queries
Name 40651 0
Ayse Mizrak
Address 40651 0
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Gaziantep, TURKEY
Country 40651 0
Turkey
Phone 40651 0
+903423606060
Fax 40651 0
+903423602938
Email 40651 0
[email protected]
Contact person for scientific queries
Name 40652 0
Vahap Saricicek
Address 40652 0
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Gaziantep, TURKEY
Country 40652 0
Turkey
Phone 40652 0
+903423606060
Fax 40652 0
+903423602938
Email 40652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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