NCT03498547

Caudal Block,Saddle Block, Anorectal Surgery

Comparison of Caudal Block and Saddle Block on Anorectal Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Kocaeli Derince Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anorectal Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-06-20
• Primary completion: 2018-08-15
• Completion: 2018-10-15
• First posted: 2018-04-13
• Last updated: 2018-12-27

Locations

2 sites across 1 country: Turkey (Türkiye)