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Caudal Block,Saddle Block, Anorectal Surgery

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ClinicalTrials.gov Identifier: NCT03498547
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
tahsin şimşek, Kocaeli Derince Education and Research Hospital

Brief Summary:
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 analgesia in perioperative period and decrease the length of stay in the hospital. 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.

Condition or disease Intervention/treatment Phase
Anorectal Disorder Procedure: caudal block Procedure: saddle block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Caudal Block and Saddle Block on Anorectal Surgery
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : October 15, 2018

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.
Procedure: caudal block
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.
Procedure: 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 ultrasonographyguidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498547


Locations
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Turkey
Derince Eğitim Ve Araştırma Hastanesi
Kocaeli, Derince, Turkey, 41000
Şimşek
Kocaeli, Derince, Turkey, 41000
Sponsors and Collaborators
Kocaeli Derince Education and Research Hospital
Investigators
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Principal Investigator: tahsin şimşek, MD KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ
Study Director: kemal tolga saracoğlu, MD KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ

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Responsible Party: tahsin şimşek, specialist doctor, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03498547    
Other Study ID Numbers: 2017-384
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by tahsin şimşek, Kocaeli Derince Education and Research Hospital:
caudal block
saddle block
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents