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Spinal Anesthesia Versus Erector Spina Plane Block

Primary Purpose

Inguinal Hernia Repair, Postoperative Pain, Peripheral Nerve Blocks

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
İnguinal Hernia Repair
Sponsored by
Nigde Omer Halisdemir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia Repair focused on measuring nerve block, inguinal hernia, anesthesia, spinal

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing inguinal hernia repair.
  • Unilateral inguinal hernia.
  • Patients with ASA II-III preoperative anesthesia score.

Exclusion Criteria:

  • Patients with liver disease,
  • allergy to anesthetic agents
  • local infection,
  • recurrence,
  • strangulated hernia,
  • patients with a history of allergy to local anesthetics,
  • patients with a history of anesthesia up to two weeks ago

Sites / Locations

  • Mustafa KAÇMAZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group SA

Group ESP+TA

Arm Description

Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied.

Group 2 (Errector spina block + TA) (n = 35): 2% lidocaine hydrochloride (10 mg / ml) 15 ml, 0.5% bupivacaine hydrochloride (20 mg / ml) 15 ml, serum 8.4% Sodium Bicarbonate 5 ml to be used for each patient before the operation in order to apply the erectile spina block block with tumescent anesthesia. Adding adrenaline tartrate (5 μg / mL) to 5 ml with saline, a total of 40 ml of mixture was prepared. Hydrodissection was achieved using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle on the Transverse Process of L1. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point.

Outcomes

Primary Outcome Measures

Intraoperative pain score
The pain level felt by the patients during the operation will be measured using a visual analog scale. The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.0 means being painless and 10 means the most severe pain.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2021
Last Updated
December 26, 2022
Sponsor
Nigde Omer Halisdemir University
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1. Study Identification

Unique Protocol Identification Number
NCT05073055
Brief Title
Spinal Anesthesia Versus Erector Spina Plane Block
Official Title
Comparison of Spinal Anesthesia and Erector Spina Plane Block in Unilateral Inguinal Hernias: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
December 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nigde Omer Halisdemir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of our study was to use spinal anesthesia for unilateral inguinal hernia surgery and lumbar erector spina block supported by local infiltration anesthesia in terms of operation time, intraoperative hemodynamic data, motor block onset time, block termination time, analgesic need, discharge time, patient satisfaction, surgeon satisfaction. is to compare. Its second purpose is to observe nausea, vomiting, urinary retention, headache, chills, bleeding, wound infection.
Detailed Description
Seventy cases of the American Society of Anesthesia physical status (ASA) I-III class between the ages of 18-75 who were hospitalized in the general surgery clinic with the diagnosis of unilateral inguinal hernia will be enrolled in this study prospectively and randomly. The entire work will be conducted in accordance with the principles of the Declaration of Helsinki. The patients will be determined one day in advance with the single-blind method and the closed envelope method, and all patients will be informed about the study plan in detail, and informed patient consent will be obtained. Patients with liver disease, allergy to anesthetic agents, local infection, recurrence, strangulated hernia, patients with a history of allergy to local anesthetics, and patients with a history of anesthesia up to two weeks ago will be excluded from the study. The general surgeon who performs the inguinal hernia repair surgery will not take part in the postoperative follow-up of the patients. Patients with a diagnosis of inguinal hernia who are operated on in our hospital are administered 0.1 mg.kg-midazolam 30 minutes before the block application. Electrocardiogram (ECG), heart rate (HR), peripheral oxygen saturation (SpO2) are monitored in the pre-anesthesia preparation room, and nasal hydration application with 2 l / min O2 and 5 ml kg hr, 0.9% NaCl is started. These patients will be randomly divided into two groups. Patients who underwent spinal anesthesia will be named as Group 1, and patients who underwent Erectile Spina Block and Tumescent anesthesia as Group 2. Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation, is taken to a seated position on the operating table and a 25 gauge spinal needle under sterile conditions (dominant, Turkey) subarachnoid space entered% in 30 seconds 0, 5 units of levobupivacaine 3 mL is injected. The intervention is started after the patients are placed in the supine position immediately after the spinal block and the level of the sensory block is confirmed by the pin prick test to be at the T10 dermatome. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied. Group 2 (Errector spina block + TA) (n = 35): To be used for each patient before the operation to apply tumescent anesthesia-assisted erectile spina block to patients undergoing unilateral inguinal hernia operation in our hospital with erectile spina block + infiltration anesthesia method. A total of 30 ml of mixture is prepared including lidocaine hydrochloride 10mg / ml, adrenaline tartarate (1: 1000) 5 μg / mL, 13 ml in total, 0.5% bupivacaine hydrochloride 13 ml, Sterile Serum 8.4% Sodium Bicarbonate 4 ml. After hemodynamic stability, the patient is placed in the lateral position and infiltration anesthesia with 2% lidocaine is applied. Following aseptic preparation of the skin and probe, a high-frequency linear USG transducer is moved 2.5 cm laterally in the parasagittal plane to visualize the transverse projection of the first lumbar (L1) vertebra. The needle, with real-time imaging of the spreading injected material, TP of L1 and at this level, just below the erector spina muscle, 5 cm, 21G peripheral nerve block needle (Pajuk®, stimuplex HNS12 Germany, Germany) is preferred. During the application, the needle is inserted perpendicular to the skin. Unilateral block is applied at T12 and L1 levels, with 10 ml in each segment. After the needle is withdrawn, pressure is applied to the injection area for 2 minutes and then, the patient is taken to the operation room, the prepared local anesthetic mixture is applied to the patient using the step-by-step technique, 5 ml under the skin and the subcutaneous area around the incision, and the other 5 ml under the fascia, the funiculus (spermatic cord). Tumescent anesthesia is applied around the area and the tissues at the base of the hernia sac. Surgery is permitted in patients who develop sensory block between T10-L1 dermatomes. In our study, patients whose sensory block is controlled by pin-prick test, and patients whose local anesthesia does not create sufficient sensory block to start the skin incision will be excluded from the study and additional anesthesia methods will be applied. The time during which the sensory blocks of the patients disappear will be recorded. During surgery, the sedation level of the patients will be monitored with the Ramsey sedation score (1: agitated, anxiosis, 2: cooperative, 3: response to verbal commands, 4: vivid response to glabella hit or loud stimulus, 5: lazy response to glabella beat or loud stimulus, 6 : no answer).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Repair, Postoperative Pain, Peripheral Nerve Blocks
Keywords
nerve block, inguinal hernia, anesthesia, spinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Spinal anesthesia was determined as the standard method. Erectile spina block was determined as a research group. There were equal numbers of patients in both groups. The patients to be assigned to the groups were determined by the closed envelope drawing method.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group SA
Arm Type
Active Comparator
Arm Description
Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied.
Arm Title
Group ESP+TA
Arm Type
Active Comparator
Arm Description
Group 2 (Errector spina block + TA) (n = 35): 2% lidocaine hydrochloride (10 mg / ml) 15 ml, 0.5% bupivacaine hydrochloride (20 mg / ml) 15 ml, serum 8.4% Sodium Bicarbonate 5 ml to be used for each patient before the operation in order to apply the erectile spina block block with tumescent anesthesia. Adding adrenaline tartrate (5 μg / mL) to 5 ml with saline, a total of 40 ml of mixture was prepared. Hydrodissection was achieved using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle on the Transverse Process of L1. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point.
Intervention Type
Procedure
Intervention Name(s)
İnguinal Hernia Repair
Other Intervention Name(s)
Erectör spinae block, Spinal Anesthesia
Intervention Description
After hemodynamic stability, the patient was placed in the lateral position and infiltration anesthesia with 2% lidocaine was applied. Following aseptic preparation of the skin and probe, a medium-frequency curvey USG transducer was first placed in the midline to visualize the transverse projection of the first lumbar (L1) vertebra, then moved 2.5 cm laterally in the parasagittal plane, after imaging the transverse process, in-plane spreading was injected. Hydrodissection was achieved on the TP of L1 by using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle with real-time imaging of the substance. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point.
Primary Outcome Measure Information:
Title
Intraoperative pain score
Description
The pain level felt by the patients during the operation will be measured using a visual analog scale. The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.0 means being painless and 10 means the most severe pain.
Time Frame
5 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing inguinal hernia repair. Unilateral inguinal hernia. Patients with ASA II-III preoperative anesthesia score. Exclusion Criteria: Patients with liver disease, allergy to anesthetic agents local infection, recurrence, strangulated hernia, patients with a history of allergy to local anesthetics, patients with a history of anesthesia up to two weeks ago
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa KAÇMAZ, Md
Organizational Affiliation
Ömer Halisdemir Üniversity
Official's Role
Study Director
Facility Information:
Facility Name
Mustafa KAÇMAZ
City
Niğde
ZIP/Postal Code
51300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Group information, intraoperative and postoperative pain scores, amount of analgesic use, and length of stay in the hospital will be shared.
Citations:
PubMed Identifier
29980003
Citation
Aksu C, Gurkan Y. Opioid sparing effect of Erector Spinae Plane block for pediatric bilateral inguinal hernia surgeries. J Clin Anesth. 2018 Nov;50:62-63. doi: 10.1016/j.jclinane.2018.06.048. Epub 2018 Jul 1. No abstract available.
Results Reference
result
PubMed Identifier
30076575
Citation
Schwartzmann A, Peng P, Maciel MA, Forero M. Mechanism of the erector spinae plane block: insights from a magnetic resonance imaging study. Can J Anaesth. 2018 Oct;65(10):1165-1166. doi: 10.1007/s12630-018-1187-y. Epub 2018 Aug 3. No abstract available.
Results Reference
result
PubMed Identifier
29670771
Citation
Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
Results Reference
result

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Spinal Anesthesia Versus Erector Spina Plane Block

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