Sacral Erector Spinae Plane Block(ESPB) in Lumbar Discectomy (ESPB)

September 7, 2023 updated by: Bilge Olgun Keles

The Effect of an Ultrasound-guided Sacral Erector Spinae Plane Block on the Post-operative Pain of Lumbar Discectomy Surgery

Several studies have shown that sacral espb blocks the dorsal ramus of spinal nerves. In lumbar discectomy operations, innervation of all tissues where pain occurs is provided by the dorsal ramus of the nerves. Based on this information, it was thought that sacral espb would be effective in lumbar discectomies. The investigators wanted to look at the effects of sacral erector spinae plane block on postoperative pain and opioid consumption in lumbar discectomy operations. There is no randomised controlled study on sacral espb in the literature. The researchers think that the results of the study are promising. Sacral espb is an easy-to-administer block with a low risk of complications and can be used effectively in lumbar discectomy analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomised, controlled, double-blind, single-centre study was approved by our Ethics Committee (KAEK2023/06). The investigators followed the Consolidated Reporting Trials Standards (CONSORT). It was conducted in patients undergoing elective lumbar discectomy, and informed consent was obtained from the patients. They were randomised using a closed envelope technique, opened by the physician performing the block. 54 patients were included in the study, divided into two groups of 27 patients as esp block (group 1) and control group (group 2), both groups underwent standard general anaesthesia. The blocks were performed in the operating theatre at the end of the operation, before the patient woke up. The patients were unaware that the block was being performed on them. A patient-controlled analgesia (PCA) device was given to both groups by another doctor blinded to the group, and Visual Analogue Scale (VAS) scores assessed for 24 hours.

Standard monitoring (peripheral oxygen saturation, electrocardiogram, non-invasive arterial blood pressure monitoring) was performed. Anaesthesia induction was achieved with 1 mcg/kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium, and anaesthesia maintenance with 2% sevoflurane, 4 lt/min 50%/50% oxygen/nitrogen mixture. Both groups received 1 g IV paracetamol towards the end of surgery. The patients were extubated after 2 mg/kg of sugammadex and were transferred to the recovery room.

The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side.

All patient demographics, age, weight, and duration of surgery, post-operative VAS scores, blood pressure, heart rate and oxygen saturation values at 30 min, 1, 6, 12 and 24 hours, total tramadol consumption, rescue analgesic use, time of first rescue analgesic requirement, patient satisfaction and side effects were recorded.

The Shapiro-Wilk test was used to examine the normality of quantitative data. Comparison of normally distributed data was performed by independent samples t-test, and comparison of non-normally distributed data was performed by Mann-Whitney U test. Comparison of qualitative data was performed using the Pearson chi-squared test. Data were presented as mean ± standard deviation, median (minimum - maximum) and n (%). Statistical significance was accepted as p<0.05. In a previous study (9), the power analysis performed to detect a difference of 15.4 mg between the 48-hour opioid consumption values of the two groups (p<0.05) was calculated with 90% power and an effect size of 0.96, and the required sample size was determined to be 24 for each group. If 10-15% of patients were excluded from the study, 27 patients were included for each group and 54 patients in total.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Giresun
      • Merkez, Giresun, Turkey, 28100
        • Giresun Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients over 18 years of age,
  • American Society of Anesthesiology(ASA) status 1-3 group

Exclusion Criteria:

  • Patients who refused to participate in the study
  • Patients with known neuromuscular and haematological diseases
  • Allergy to local anaesthetics
  • Contraindications to regional anaesthesia
  • Anatomical changes in the lumbo-sacral region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: espb group
The first group underwent sacral espb at the end of surgery. The lumbosacral region was sterilised with povidine iodine and then draped with the patient in prone position. The linear ultrasound probe was placed in the midline on the spinous process of the 5th lumbar vertebra after the sterile covering had been applied. After observation of the sacrum, the level of the 2nd median crest was determined and the ultrasound probe was moved 1.5-2 cm laterally and the 2nd intermediate crest and the erector spinae muscle between the two were observed. 22 G 50 mm needle was advanced from caudal to cranial direction to the sacral crest using in-plane technique, after confirming the needle position with 1-2 ml saline, 0.25% bupivacaine 20 ml was administered, local anaesthesia was observed to spread cauda-cranially separating the erector spinae muscle from the sacral crest, the same procedure was performed on the opposite side
Procedure: sacral erector spinae plane block
espb from bilateral sacral level 2 with 20 ml %0,25 bupivacaine
No Intervention: control group
The second group had no any block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient pain scores
Time Frame: 24 hours
Visual Analog Scala (0:No pain 10: Worst pain possible)
24 hours
Patient total opioid consumption
Time Frame: 24 hours
The number of patient controlled analgesia device boluses doses
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea-vomiting
Time Frame: 24 hours
The incidence of side effects described yes or no
24 hours
Patient satisfaction
Time Frame: 24. hours
Patient satisfaction (0:Not satisfied 10:Very satisfied)
24. hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bilge Olgun Keles

Investigators

  • Study Director: Bilge Olgun Keleş, M.D., Giresun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since it is the first study on this subject in the literature

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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