Continuous Erector Spinea Block Versus Intravenous Analgesia in Coronary Bypass Surgery

NCT03866733 | Completed DMC

• 1 other identifier: R07l2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Erector Spinea Block in Open Heart Surgery

Keywords

erector spinea block, open heart surgeries,analgesia

Outcome Measures

Primary Outcomes (1)

• effectiveness of perioperative analgesia

  total dose of perioperative narcotics

  48 hours after surgery

Secondary Outcomes (1)

• extubation time

  12 hours after end of surgery

Study Arms (2)

Narcotics group (group N)

ACTIVE COMPARATOR

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

Erector spinea block group (group B)

EXPERIMENTAL

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

continous erector spinea block OTHER

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.

Erector spinea block group (group B)

intravenous narcotics DRUG

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

Narcotics group (group N)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Sanaa Farag Mahmoud

Cairo, New Cairo, 11835, Egypt

Location

Ainshams hospitals

Cairo, 11591, Egypt

Location

Related Publications (5)

• 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.

  PMID: 18201893 BACKGROUND

• 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.

  PMID: 24319854 BACKGROUND

• 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.

  PMID: 16394700 BACKGROUND

• 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.

  PMID: 11426357 BACKGROUND

• 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.

  PMID: 12688271 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Narcotics; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of aneathesia

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 7, 2019
• Study Start: March 18, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 10, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)