Effects of Erector Spinae Plane Block on Opioid Consumption, Anesthetic Consumption and Hemodynamics in Lumbar Disc Herniation Surgeries.

NCT06933498 | Recruiting

• 1 other identifier: 2024-KAEK-24/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar disc herniation (LDH) is an increasingly common spine disorder . In patients treated surgically, inhalation anesthesia and the use of opioids for analgesic purposes are generally the chosen anesthetic methods. Surgical techniques such as discectomy, microdiscectomy, and stabilization (REF) are used to treat LDH. Although discectomy is considered the primary option in the treatment of LDH, less invasive techniques such as microdiscectomy have been applied in recent years . However, despite the use of less invasive techniques, patients experience pain after surgery . Clinicians want to avoid complications such as thromboembolism and hemodynamic deterioration that may occur due to postoperative pain, and to apply effective pain treatment for patient comfort and rapid discharge from the hospital. It has also been stated that inadequate postoperative pain treatment may increase the risk of developing chronic pain. Therefore, the use of opioids for analgesic purposes in the intraoperative and postoperative periods is quite common. However, opioid use may cause side effects that negatively affect postoperative recovery and may delay discharge. Some of these situations include delayed recovery from anesthesia, failure to perform early postoperative neurological examination due to delayed recovery, postoperative nausea and vomiting (PONV), pruritus, urinary retention, respiratory depression, gastrointestinal dysfunction, and addiction. Another important issue is the difficulty of applying effective treatment to patients, the side effects that develop due to the applied treatments, and the increase in healthcare costs, which are important problems. Therefore, it is also very important to take a cost-effective approach while trying to treat patients at the highest level. The applied anesthesia and analgesia methods can also significantly affect the cost of surgical treatments. In particular, inhalation anesthetics used in patients receiving general anesthesia and opioids used for intraoperative and postoperative analgesia constitute a significant portion of the anesthesia cost. Therefore, strategies that will provide cost savings by reducing the use of both inhalation anesthetics and opioids are emphasized. In this context, nerve blocks or fascial plane blocks applied with local anesthetics come to the fore. With the widespread use of ultrasonography in regional anesthesia practice, regional plane blocks have also become widespread in parallel with this development and have begun to take more place in the literature. Erector spinae plane block (ESPB) is also among these blocks that are increasingly gaining ground in the literature. ESPB is a technique defined for both acute and chronic pain. ESPB is performed by administering local anesthetic (LA) to the fascial plane between the transverse process of the vertebra and the overlying erector spinae muscle. When literature data are examined, ESPB can be applied from the thoracic or lumbar levels in LDH surgery, before and after preoperative anesthesia induction, intraoperatively, at the end of surgery, before extubation or in the postoperative period. ESPB can be applied with the patient in the prone position, sitting or lateral decubitus position. In studies conducted on patients undergoing laparoscopic cholecystectomy, it was found that ESPB reduced the amount of intraoperative inhalation anesthetic and opioid consumption. In another study examining the effect of ESPB on lumbar spine surgeries, it was found that ESPB reduced the use of intraoperative fentanyl and isoflurane and significantly shortened the recovery time. In addition, ESPB is thought to provide more effective analgesia in postoperative pain management and reduce opioid consumption and opioid-related side effects after lumbar spine surgeries. According to the results of published studies, it has been stated that ESPB is more effective for postoperative analgesia in patients undergoing lumbar surgery, significantly reduces pain scores at rest (static) and during activity (dynamic), provides a significant decrease in 24-hour opioid consumption, prolongs the first analgesic requirement period and is associated with fewer side effects. Another important issue is to keep intraoperative hemodynamics stable within normal limits in patients under general anesthesia. Hemodynamic stability is very important to ensure that the amount of bleeding from the surgical site is kept at a minimum level, especially during LDH surgeries. It has been stated that the combined application of regional anesthesia and general anesthesia in spinal surgery provides better pain control as well as better hemodynamic stability. This study aimed to compare the effects of preoperative and intraoperative ESPB on opioid consumption, anesthetic drug consumption, and hemodynamics in LDH surgeries.

Conditions

Erector Spina Plan Block; Opioid Consumption; Postoperative Pain

Keywords

Lumbar disc herniation surgery.; Erector spinae plane block; Anesthetic drug consumption; Opioid consumption; Perioperative hemodynamics

Outcome Measures

Primary Outcomes (2)

• opioid consumption

  The total amount of morphine consumption

  24 hours

• anesthetic consumption

  The total amount of sevoflurane consumption at the end of the surgery

  24 hours

Study Arms (2)

PREOPERATİVE ESPB

ACTIVE COMPARATOR

After 0.03 mg/kg IV midazolam sedation is applied to patients who will undergo preoperative ESPB, bilateral ultrasound-guided ESPB (in-plane approach) will be applied over the vertebral level that is equidistant from the highest and lowest vertebral levels planned for surgery in the prone position. ESPB will be performed by experienced anesthesiologists. After sterilization of the skin with povidone iodine, the probe with a sterile sheath is placed 3 cm lateral to the spinous process and the trapezius, rhomboid major, erector spinae muscles and the transverse process of the vertebrae are visualized. The needle is placed in the fascial plane on the deep surface of the erector spinae muscle on the bone shadow of the transverse process of the vertebra. A total of 40 mL of 0.25% bupivacaine is administered bilaterally after the LA spread is seen. After waiting for the effect of the block for 30 minutes, the patients will be taken to the operating room.

Procedure: PREOPERATIVE ESPB

INTRAOPERATİVE ESPB

ACTIVE COMPARATOR

Intraoperative ESPB will be performed by the neurosurgeon after LDH repair, starting from the level of the operated vertebra and covering all surgical segments. This procedure will be repeated for the other side (right/left). A total of 40 mL of 0.25% bupivacaine will be used for both sides.

Procedure: INTRAOPERATIVE ESPB

Interventions

PREOPERATIVE ESPB PROCEDURE

After 0.03 mg/kg IV midazolam sedation is applied to patients who will undergo preoperative ESPB, bilateral ultrasound-guided ESPB (in-plane approach) will be applied over the vertebral level that is equidistant from the highest and lowest vertebral levels planned for surgery in the prone position. ESPB will be performed by experienced anesthesiologists. After sterilization of the skin with povidone iodine, the probe with a sterile sheath is placed 3 cm lateral to the spinous process and the trapezius, rhomboid major, erector spinae muscles and the transverse process of the vertebrae are visualized. The needle is placed in the fascial plane on the deep surface of the erector spinae muscle on the bone shadow of the transverse process of the vertebra. A total of 40 mL of 0.25% bupivacaine is administered bilaterally after the LA spread is seen. After waiting for the effect of the block for 30 minutes, the patients will be taken to the operating room.

PREOPERATİVE ESPB

INTRAOPERATIVE ESPB PROCEDURE

Intraoperative ESPB will be performed by the neurosurgeon after LDH repair, starting from the level of the operated vertebra and covering all surgical segments. This procedure will be repeated for the other side (right/left). A total of 40 mL of 0.25% bupivacaine will be used for both sides.

INTRAOPERATİVE ESPB

Eligibility Criteria

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

You may qualify if:

• Those over 18 and under 75 years of age,
• Those with an American Society of Anesthesiologists (ASA) score of I-II-III,
• Those with a body mass index (BMI) between 18-40 kg/m2
• Patients undergoing surgery with general anesthesia
• Patients undergoing LDH surgery (levels 1, 2, and 3)
• Patients with informed consent

You may not qualify if:

• Patients with severe cardiovascular system disease,
• Patients with coagulation disorders,
• Those allergic to the anesthetic and analgesic drugs to be administered,
• Patients with infection at the injection site,
• Patients with severe renal failure, gastrointestinal ulceration or severe asthma that prevents standard analgesia protocol
• Patients who have previously undergone LDH surgery at the same level,
• Patients who are planned to have surgery at more than 3 levels
• Patients with ASA 4 and above,
• Patients who are planned with total intravenous anasthesia(TIVA)

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Hatice Karabulut

  Ankara Atatürk Sanatorium Training and Research Hospital Recruiting Ankara, Keçiören, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatice Karabulut

CONTACT

+905438988116; drhaticekarabulut95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Associate Professor

Model Details: Patients who volunteer to participate in the study will be randomly assigned to the patient groups that will receive preoperative ESPB and intraoperative ESPB in a 1:1 ratio. This process will be performed using a computer-based program that follows a random number generator protocol. Patients will be classified using the online calculator at www.calculator.net. A random number will be assigned to each patient according to the calculator output. The group to be applied preoperative ESPB will include patients between numbers 1 and 30, and the group to be applied intraoperative ESPB will include patients between numbers 31 and 60.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 18, 2025
• Study Start: April 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)