Spinal Anesthesia Versus Erector Spina Plane Block

NCT05073055 | Completed

• 1 other identifier: 2020/38
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia Repair; Postoperative Pain; Peripheral Nerve Blocks

Keywords

nerve block; inguinal hernia; anesthesia; spinal

Outcome Measures

Primary Outcomes (1)

• 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.

  5 month

Study Arms (2)

Group SA

ACTIVE COMPARATOR

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.

Procedure: İnguinal Hernia Repair

Group ESP+TA

ACTIVE COMPARATOR

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.

Procedure: İnguinal Hernia Repair

Interventions

İnguinal Hernia Repair PROCEDURE

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.

Also known as: Erectör spinae block, Spinal Anesthesia

Group ESP+TA; Group SA

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Mustafa KAÇMAZ

Niğde, 51300, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 29980003 RESULT

• 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.

  PMID: 30076575 RESULT

• 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.

  PMID: 29670771 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mustafa KAÇMAZ, Md

  Ömer Halisdemir Üniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology department director

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: October 11, 2021
• Study Start: January 1, 2021
• Primary Completion: September 28, 2021
• Study Completion: December 25, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)