Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03997227
Collaborator
(none)
68
1
2
14
4.8

Study Details

Study Description

Brief Summary

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector spinae Block
N/A

Detailed Description

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

ASA I-III, 68 patients between 18-75 years of age were planned to be included in the study. 34 participants were expected to be included in the control and implementation group.

In our study, the ESP block was planned to be applied to the patients in the block group. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol, intravenous paracetamol 1 gr and tramadol 1 mg / kg were determined. Then, every eight hours, paracetamol and contromal infusion.

At the end of the operation, the patients will be determined by the Numeric Rating Scale (NRS) system at the 30th hour, 1st, 6th, 12th and 24th hours after the first hour of the operation. Tramadol PCA and paracetamol are administered every eight hours.

Age, sex, weight, body mass index, application of ESP block, time of surgery, duration of surgery, evaluation of pain in postoperative recovery room and 24-hour follow-up will be recorded when the patient is mobilized and discharged.

It is thought that the ESP block will decrease postoperative pain by providing effective pain control after surgery in patients undergoing lumbar vertebra surgery. In addition, it is thought to accelerate mobilization in the postoperative period and shorten the time of discharge.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial
Actual Study Start Date :
May 2, 2019
Anticipated Primary Completion Date :
May 2, 2020
Anticipated Study Completion Date :
Jul 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Block group

Procedure: Erector spinae Block
After anesthesia and surgical procedures, a bilateral ESP block with ultrasound guidance will be applied from the T10 level at the middle line 3 cm lateral. Prior to the block, with povidone iodine, the T10 transverse protrusion will be determined by using linear ultrasound probe. The local anesthetic will be applied between the transverse projection and the erector spina muscle with the help of an isolated needle designed for peripheral block operations. Without local anesthesia, the location of the needle with saline will be confirmed by hydrodissection. After confirming the location of the needle, 20 ml of LA and saline mixture will be applied and the same procedure will be repeated in the control. A total of 40 ml of LA, 20 ml of bupivacaine 0.5%, 10 ml of lidocaine 2%, 10 ml of saline will be composed of saline.

No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. NRS(numerical rating scala) [24 hours]

    Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours

  2. pruritus, nausea and vomiting, use of antiemetics [24 hours]

    each criterion is reported as present or absent each criterion is reported as present or absent

  3. mobilized , discharged [7 days]

    each criterion is reported as when the patient is mobilized and when he is discharged

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 68 patients

  • ASA I-III,

  • Aged 18-75 years

  • underwent lumbar spine surgery under elective conditions

Exclusion Criteria:
  • Presence of contraindications to LA agents used in this study

  • Use of chronic opioids,

  • Psychiatric disorders.

  • Surgical procedures that lasted <60 minutes or> 300 minutes

  • The presence of infection at the injection area.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adnan Menderes Univesity Aydın Turkey

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Sinem Sarı, Aydin Adnan Menderes University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sinan ASAR, Principal Investigator, clinical research, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT03997227
Other Study ID Numbers:
  • 2019/04
First Posted:
Jun 25, 2019
Last Update Posted:
Jun 27, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2019