Caudal Block,Saddle Block, Anorectal Surgery

NCT03498547 | Completed

• 1 other identifier: 2017-384
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Anorectal Disorder

Keywords

caudal block; saddle block

Outcome Measures

Primary Outcomes (1)

• The goal is to create adequate anesthesia for the surgeon to be painless

  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 Outcomes (1)

• The goal is to provide pain relief in the postoperative period

  Postoperative follow-up for analgesia is 24 hours.

Study Arms (2)

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.

Procedure: caudal block

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.

Procedure: saddle block

Interventions

caudal block PROCEDURE

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.

Caudal Block

saddle block PROCEDURE

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.

Saddle Block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old patients
• ASA 1-2 patients
• Patients who will undergo anorectal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli Derince Education and Research Hospital: lead

Study Sites (2)

Derince Eğitim Ve Araştırma Hastanesi

Kocaeli, Derince, 41000, Turkey (Türkiye)

Location

Şimşek

Kocaeli, Derince, 41000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rectal Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• tahsin şimşek, MD

  KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ

  PRINCIPAL INVESTIGATOR

• kemal tolga saracoğlu, MD

  KOCAELİ DERİNCE EĞİTİM VE ARAŞTIRMA HASTANESİ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: June 20, 2018
• Primary Completion: August 15, 2018
• Study Completion: October 15, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

TU (2)