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ESP/PIF for Sternotomy

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Mount Sinai Health System

Status and phase

Active, not recruiting
Early Phase 1

Conditions

Cardiac Surgery
Sternotomy

Treatments

Procedure: ESP block
Procedure: PIF block
Drug: Bupivacain
Procedure: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT04985500
STUDY-20-01473

Details and patient eligibility

About

This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.

90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.

Enrollment

225 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults 18-85 years old
  • Scheduled to undergo cardiac procedures involving sternotomy
  • All genders

Exclusion criteria

  • ASA class V
  • Urgent or emergent surgery
  • Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
  • History of substance abuse or chronic opioid use
  • Patient refusal or inability to consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

225 participants in 3 patient groups

ESP group
Experimental group
Description:
Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.
Treatment:
Procedure: Ultrasound
Drug: Bupivacain
Procedure: ESP block
PIF group
Experimental group
Description:
Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.
Treatment:
Procedure: Ultrasound
Drug: Bupivacain
Procedure: PIF block
No Block group
No Intervention group
Description:
Patient will not receive block.

Trial contacts and locations

1

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Central trial contact

Shenghao Fang, M.D.; Ali Shariat, M.D.

Data sourced from clinicaltrials.gov

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