Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery

February 13, 2024 updated by: University of Malaya
The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Most open spine surgery exacts a high degree of postsurgical pain due to the incision and muscle dissection of the vertebra. The postoperative pain control and early mobilization improve the quality of the surgical care. Inadequate pain relief might result in perioperative morbidity, resulting in prolonged hospital stays.

Erector spinae plane block (ESPB) is an interfascial plane block where local anaesthetic is injected in a plane preferably below the erector spinae muscle. It can provide thoracic, abdominal, and even some lower extremity analgesia. It was also theorised that erector spinae plane block can reduce opioid use and provide analgesia for lumbar surgery. The financial cost that is saved by reducing the length of hospital stay, perioperative morbidity will warrant the use of erector spinae plane block in patients undergoing lumbar spine surgery.

Study Type

Interventional

Enrollment (Estimated)

40

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

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 51100
        • Recruiting
        • Universiti Malaya Medical Centre
        • Contact:
        • Principal Investigator:
          • Wei Keang Tan, MD.
        • Sub-Investigator:
          • Tzi Sen Lee, MBBS
        • Sub-Investigator:
          • Dharmendra Ganesan, MBBS, FRCS

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:

  • Age 18-75
  • Patients with Glasgow Coma Scale of 15.
  • American Society of Anaesthesiologists (ASA) Physical Status Classification I - II patients
  • Scheduled for elective, open microscopic lumbar surgery (less than 3 levels) under general anesthesia.

Exclusion Criteria:

  • Cognitive impairment
  • Patient refusal
  • Weight<50kg, >120kg
  • Allergy to local anesthesia
  • Alcohol/ drug abuse
  • Renal failure or liver failure
  • Coagulopathy/thrombocytopenia
  • Chronic pain with chronic opioid usage
  • Ischemic heart disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Pre incision of 0.375% ropivacaine 10ml local infiltration will be given.
Procedure: Skin infiltration LA
Pre incision of 0.375% ropivacaine 10ml local infiltration will be given to control group
Experimental: Ropivacaine group
Bilateral erector spinae plane block (0.375% 20ml ropivacaine on each side + adrenaline 1:200,000) pre incision.
Procedure: Erector spinae plane block

After consent was obtained, patients will be randomised into control group and an intervention group. For patients randomized into the interventional group, bilateral erector spinae plane block will be performed under general anaesthesia in prone position before the operation. An experienced anaesthetist performs this under ultrasound guidance (using curvilinear probe) in a sterile method.

After identifying L3 transverse process, 21G Stimuplex needle will be inserted via in-plane method. Once needle placement is confirmed and aspiration is negative, 20ml of ropivacaine 0.375% with adrenaline 1:200,000 dilution will be given on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery
Time Frame: 24 hours
Measure by numerical rating scale (minimum 1-least pain, maximum 10-most painful)
24 hours
Total opioid consumption intraoperative
Time Frame: 48 hours
Measure by total dose consumed (in milligram)
48 hours
Total opioid consumption post-operative
Time Frame: up to 72 hours
Measure by total dose consumed (in milligram)
up to 72 hours
Timing of first rescue dose of iv morphine
Time Frame: up to 24 hours
Post operation till time requiring first dose of iv morphine
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation
Time Frame: 24 hours
Measure by the quality of recovery score (QoR)-15 questionnaire (minimum of 0,maximum of 150,higher score means a better outcome)
24 hours
Hemodynamic changes intraoperative
Time Frame: Intraoperative period
Blood pressure(measure in mm hg)
Intraoperative period
Hemodynamic changes intraoperative
Time Frame: Intraoperative period
heart rate (heart rate measure via heart beats per minute/ECG)
Intraoperative period
Length of hospital stays
Time Frame: up to 1 week
Days of stay in hospital
up to 1 week
Time to ambulation after surgery
Time Frame: up to 1 week
Time from operation till ambulation
up to 1 week

Collaborators and Investigators

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

Sponsor

University of Malaya

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 (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023322-12280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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