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Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients

Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749395
Enrollment
60
Registered
2018-11-21
Start date
2018-12-05
Completion date
2019-11-05
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

PROCEDUREErector Spinae Plane Block

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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The practitioner and the patient are not blinded.The outcomes assessor will not know which group each patient is in.

Intervention model description

Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
24 hours morphine consumption24 hours postoperativetotal morphine consumption in both groups will be assessed in the postoperative period

Secondary

MeasureTime frameDescription
The quality of analgesia based on visual analogue scale (VAS) pain scores.every 6 hours for 24 hoursVAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Side effects of opioid usage2, 6, 12, 24 hours postoperativeAny evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.
Procedural morbidity2, 6, 12, 24 hours postoperativeAny evidence of procedure-related morbidity

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026