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CompletedNCT03866733Updated Jan 15, 2021

Continuous Erector Spinea Block Versus Intravenous Analgesia in Coronary Bypass Surgery

An interventional study of continous erector spinea block and intravenous narcotics in Erector Spinea Block in Open Heart Surgery, sponsored by Ain Shams University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Adequate postoperative pain relief in patients in cardiac surgery is very essential. multimodal techniques for perioperative pain management post cardiac surgery include intravenous patient controlled analgesia, thoracic epidural and paravertebral blockade. Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control but it has serious complications. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural. Hence, this study will compare continuous bilateral erector spinae block guided by ultrasound with intravenous analgesia which is the standard method for pain management in cardiac surgery.

Read the detailed description

Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control. in spite of its serious complications such as epidural hematoma with or without paraplegia that enhanced by heparin administered during cardiac bypass surgery..

Paravertebral blockade is comparable to Thoracic epidural analgesia in cardiac surgery but it may cause complications such as vascular injuries and pneumothorax.

Erector spinae block is recently implemented technique for treatment and analgesia of thoracic neuropathic pain and post mastectomy syndrome. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural.

This study will compare continuous bilateral erector spinae block guided by ultrasound versus intravenous analgesia for pain management in cardiac surgery Patients will be enrolled in the study will be divided into two groups In Group A: 20 patients will receive fentanyl after induction and intubation in the dose of ( 3-52mcg/kg ) according to the patients haemodynamic parameters and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU. After ICU transfer acetaminophen 1 gm/6hrs will be given regularly and NSAID if there is no contraindication after extubation. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation.

In Group B: 20 patients will have bilateral ESP block will be done under general anaesthesia bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h starting in ICU for 48 h after extubation. patients will receive intraoperative boluses of fentanyl according to the patients' haemodynamic and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation. Infusion rate will be titrated according to haemodynamics, pain assessment, and complications. After extubation acetaminophen 1gm/6hrs will be given regularly.

02

Conditions studied

  • Erector Spinea Block in Open Heart Surgery

Keywords

  • erector spinea block, open heart surgeries,analgesia
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • elective cardiac surgery.
  • age 18-65 years.
  • patients with median sternotomy.
  • body mass index \<30kg.m2.
  • left ventricular ejection fraction >50%.

Exclusion criteria

Exclusion Criteria:

  • significant aortic stenosis.
  • left main coronary artery disease.
  • patient on anti-coagulants0
  • pre-existing respiratory, neurological, or renal disease.
  • CSF or blood tap during the procedure.
  • failure to thread the catheter.
  • anomalies of vertebral column.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Narcotics group (group N)

    intervention: injection of boluses of intra venous Narcotics (fentanyl) in the dose of (3-5 mcg/kg) during the surgery after induction of anesthesia. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till 48 hours after surgery. NSAID every 12 hrs if there is no contraindication and iv acetaminophine igm/6hrs.

    Drug: intravenous narcotics

  • Experimental
    Erector spinea block group (group B)

    intervention: after induction our intervention will be the performance of ultrasound guided bilateral continous Erector spinea block with insertion of catheters then 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation and iv acetaminophine igm/6hrs.

    Other: continous erector spinea block

Interventions

  • Othercontinous erector spinea block

    Ultrasound guided erector spinea block will be performed while the patient is in left lateral position ) the US probe will be placed in longitudinal parasagittal plane lateral to the T5 spinous process. An 18-gauge epidural needle will be inserted in-plane in a cranial-to-caudal direction until the tip is deep to erector spinae muscle. A 5 cm of epidural catheter will be threaded in cephalad direction. The same steps will be performed on the other side, after the negative aspiration for blood, bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 0.1 ml/kg/h.

  • Drugintravenous narcotics

    intervention: injection of boluses of intra venous Narcotic drugs (fentanyl) in the dose of (1-2mcg/kg) during the surgery after induction of anesthesia then fentanyl infusion through the postoperative first 24 hours postoperative till extubation then intravenous pethidine till 48 hours after surgery.

    Also known as: iv narcotics and NSAID

06

What researchers measure

Primary outcomes

  1. effectiveness of perioperative analgesia

    total dose of perioperative narcotics

    Time frame: 48 hours after surgery

Secondary outcomes

  1. extubation time

    time passed between end of surgery and removal of endotracheal tube

    Time frame: 12 hours after end of surgery

07

Study locations

2 sites
  • Sanaa Farag Mahmoud
    Cairo, New Cairo 11835, Egypt
  • Ainshams hospitals
    Cairo, 11591, Egypt
08

References and documents

Publications

  • Fibla JJ, Molins L, Mier JM, Sierra A, Vidal G. Comparative analysis of analgesic quality in the postoperative of thoracotomy: paravertebral block with bupivacaine 0.5% vs ropivacaine 0.2%. Eur J Cardiothorac Surg. 2008 Mar;33(3):430-4. doi: 10.1016/j.ejcts.2007.12.003. Epub 2008 Jan 16. PubMed 18201893 ↗
  • Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8. PubMed 24319854 ↗
  • Hansdottir V, Philip J, Olsen MF, Eduard C, Houltz E, Ricksten SE. Thoracic epidural versus intravenous patient-controlled analgesia after cardiac surgery: a randomized controlled trial on length of hospital stay and patient-perceived quality of recovery. Anesthesiology. 2006 Jan;104(1):142-51. doi: 10.1097/00000542-200601000-00020. PubMed 16394700 ↗
  • Dhole S, Mehta Y, Saxena H, Juneja R, Trehan N. Comparison of continuous thoracic epidural and paravertebral blocks for postoperative analgesia after minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2001 Jun;15(3):288-92. doi: 10.1053/jcan.2001.23271. PubMed 11426357 ↗
  • Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x. PubMed 12688271 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03866733
Lead sponsor
Ain Shams University
Responsible party
Sanaa Farag Mahmoud Wasfy (lecturer of aneathesia, Ain Shams University) — Principal investigator
First posted
Mar 7, 2019
Start date
Mar 18, 2019
Primary completion
Sep 30, 2020
Completion
Dec 10, 2020
Last update
Jan 15, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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