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Clinical Trials/NCT03498547
NCT03498547CompletedNot Applicable

Comparison of Caudal Block and Saddle Block on Anorectal Surgery

Kocaeli Derince Education and Research Hospital4 sites in 1 country71 target enrollmentStarted: June 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
71
Locations
4
Primary Endpoint
The goal is to create adequate anesthesia for the surgeon to be painless

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Caudal Block

Active Comparator

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.

Intervention: caudal block (Procedure)

Saddle Block

Active Comparator

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.

Intervention: saddle block (Procedure)

Outcomes

Primary Outcomes

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 Outcomes

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

Investigators

Sponsor
Kocaeli Derince Education and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

tahsin şimşek

specialist doctor

Kocaeli Derince Education and Research Hospital

Study Sites (4)

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