Comparison of Caudal Block and Saddle Block on Anorectal Surgery

Caudal Block,Saddle Block, Anorectal Surgery



Sponsors


Source

Kocaeli Derince Education and Research Hospital

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Not yet recruiting

Start Date

2018-05-04

Completion Date

2018-10-15

Primary Completion Date

2018-08-15

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

The goal is to create adequate anesthesia for the surgeon to be painless
Sufficient anesthesia is expected within 30 minutes after the anesthetic agent is applied

Secondary Outcome

Measure

Time Frame

The goal is to provide pain relief in the postoperative period
Postoperative follow-up for analgesia is 24 hours.

Enrollment

100

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

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.

Arm Group Label

Caudal Block


Intervention Type

Procedure

Intervention Name


Description

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.

Arm Group Label

Saddle Block



Eligibility

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

Gender

All

Minimum Age

18 Years

Maximum Age

60 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

tahsin şimşek, MD
Principal Investigator
KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ
kemal tolga saracoğlu, MD
Study Director
KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ

Overall Contact

Last Name

tahsin şimşek, MD

Phone

+905302897559

Email



Verification Date

2018-04-01

Lastchanged Date

2018-04-12

Firstreceived Date

2018-04-06

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Kocaeli Derince Education and Research Hospital

Investigator Full Name

tahsin şimşek

Investigator Title

specialist doctor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Bupivacaine


Arm Group

Arm Group Label

Caudal Block

Arm Group Type

Active Comparator

Description

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.


Arm Group Label

Saddle Block

Arm Group Type

Active Comparator

Description

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

mehmet yılmaz, MD

Phone

+905052174432

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

None (Open Label)


Study First Submitted

April 6, 2018

Study First Submitted Qc

April 12, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 12, 2018

Last Update Submitted Qc

April 12, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on April 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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