Clinical trial NCT03749395: Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients
Official title: Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.
Primary purpose: PREVENTION

Brief summary: aim of this study is to assess and compare between the efficacy of the new U/S guided erector spinae plane block (ESP) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery.

Detailed description: Thoracotomy is considered the most painful of surgical procedures and providing effective analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing, coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae plane (ESP) block is a newly-described technique for treating thoracic pain, and has several advantages that make it an attractive alternative to these more invasive procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique, recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the paravertebral space . When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed as follow:The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.

Eligibility criteria: Inclusion Criteria:

* patients aged \>18 years
* American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy

Exclusion Criteria:

* Refusal of the patient to provide written consent
* history of relevant drug allergy
* age less than 18
* obesity BMI \> 40 kg/m2
* infection of the skin at the site of needle puncture area
* coagulopathy
* Pregnant females

Primary outcomes:
measure: 24 hours morphine consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: The quality of analgesia based on visual analogue scale (VAS) pain scores.
timeFrame: every 6 hours for 24 hours
measure: Side effects of opioid usage
timeFrame: 2, 6, 12, 24 hours postoperative
measure: Procedural morbidity
timeFrame: 2, 6, 12, 24 hours postoperative
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University Hospital
Study officials:
affiliation: faculty of medicine
name: faculty of medicine
role: STUDY_DIRECTOR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.