- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03498547
Caudal Block,Saddle Block, Anorectal Surgery
Comparison of Caudal Block and Saddle Block on Anorectal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Various surgical and anesthetic techniques have been used to increase the level of patients perioperative analgesia and decrease the length of stay in the hospital.
Spinal Saddle block anesthesia applications are performed while the patient is in the sitting position. Local anesthetic is given into the intrathecal space and it is aimed to localize the applied agent around the hip and anorectal region with the effect of gravity. Thus, sufficient level of anesthesia required during perianal region surgery and stable patient hemodynamics is provided. Caudal block is widely used in both adults and pediatric patients for intraoperative anesthesia and chronic pain management. Sacral hyperattenuation is performed to reach the epidural space, a local anesthetic agent is given to the epidural space, it is accepted as an easy and safe method and therefore it is frequently used in anorectal surgeons.
In this study, investigators investigate the effects of routinely applied anesthesia techniques during anorectal surgery, caudal block and saddle block, on patients' perioperative hemodynamic values, sensory and motor block levels, and postoperative pain scores. Elective anorectal surgery planned 100 patients between the 18-60 ages. The risk of anesthesia in patients will be determined by ASA (American Society Of anesthesiologists), ASA1 or ASA 2 risk group will be included after informed consents are approved.
Patient electrocardiogram (ECG), peripheral oxygen saturation (SpO2), non-invasive blood pressure monitor will be performed in the operation room. Baseline hemodynamic-vital parameters of the patients will be recorded. Patients undergoing caudal and saddle blocks, will be compared as two randomized groups.
In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonography guidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes.
For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ultrasonography. The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss. Sensory and motor block level, heart rate (HR), systolic arterial pressure (SAB), diastolic arterial pressure (DAB), mean arterial pressure (OAB) and SpO2 levels will be measured every 5 minutes until the end of the operation. Sensory block level will be evaluated with "pinprick" test. Motor block level will be evaluated by using Modified Bromage Scale (0 = no paralysis, thigh, leg and foot can be removed, 1 = unable to move the thigh, move the knee,2 = cannot move the knee, can move the ankle, 3 = cannot move the lower extremities at all) Once sensory block level is reached to the L3 level the surgical procedure will begin.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Derince
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Kocaeli, Derince, Turkey, 41000
- Derince Eğitim Ve Araştırma Hastanesi
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Kocaeli, Derince, Turkey, 41000
- Şimşek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-60 years old patients
- ASA 1-2 patients
- Patients who will undergo anorectal surgery
Exclusion Criteria:
- Having known hypersensitivity to amide type local anesthetics
- Patients with contraindications to central block (caudal, saddleblock): use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure, severe aortic and / or mitral valve stenosis, ischemic hypertrophic subaortic stenosis,
- Patients who do not accept regional anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Caudal Block
For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ultrasonography.
The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss.
|
For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ulştrasonography.
The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss.
|
Active Comparator: Saddle Block
In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonography guidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen.
The patient will be placed in sitting position for 5 minutes.
|
In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonographyguidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen.
The patient will be placed in sitting position for 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The goal is to create adequate anesthesia for the surgeon to be painless
Time Frame: Sufficient anesthesia is expected within 30 minutes after the anesthetic agent is applied
|
When anesthetic agent is administered, the formation of sensory block at level lumbar 3 vertabra will be considered as an adequate level of anesthesia
|
Sufficient anesthesia is expected within 30 minutes after the anesthetic agent is applied
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The goal is to provide pain relief in the postoperative period
Time Frame: Postoperative follow-up for analgesia is 24 hours.
|
Pain measurement will be done with a visual analogue scale for 24 hours from the end of the operation.
Visual Analog Scale (VAS) is used to convert some numerically unmeasured values into numeric values.
Two extremes of a 100 mm line are to be assessed on two extremes and the patient is asked to indicate on the line where his situation is appropriate by drawing a line or placing a point or pointing.
For example, for pain; no pain on one tip = 0, very severe pain = 100 on the other tip, and the patient marks his / her current state on this line.
According to this chart, values of 50 mm and above are adversely affecting patient comfort.
Patients with visual analog scale values above 50 mm will be intervened by making analgesic drugs.
|
Postoperative follow-up for analgesia is 24 hours.
|
Collaborators and Investigators
Investigators
- Principal Investigator: tahsin şimşek, MD, KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ
- Study Director: kemal tolga saracoğlu, MD, KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-384
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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