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

U

University of Malaya

Status

Enrolling

Conditions

Lumbar Spine Disease

Treatments

Procedure: Skin infiltration LA
Procedure: Erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT06270654
2023322-12280

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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