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The Goal of This Study is to Evaluate the Effect of Ultrasound Guided Erector Spinae Plane Block on Postoperative Pain After Major Abdominal Surgeries

NCT04382209 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-09-04

No results posted yet for this study

Summary

Aim of the work To evaluate the efficacy of ultrasound-guided erector spinae plane block for management of postoperative pain in patients undergoing major abdominal surgery under general anesthesia.

Hypothesis

* Null hypothesis: The investigators suppose that ultrasound-guided erector spinae plane block has no post-operative analgesic effect in patients undergoing major abdominal surgery.
* Alternative hypothesis: The investigators suppose that ultrasound-guided erector spinae plane block has post-operative analgesic effect in patients undergoing major abdominal surgery.

Study objectives

Primary Objective:

Comparison of opioid consumption in patients receiving erector spinae plane block in relation to control group.

Secondary Objective:

1. Evaluate the hemodynamics (blood pressure, heart rate) and respiratory rate in patients receiving erector spinae plane block during postoperative period at 0, 2, 4, 6, 8, 12,24 hours.
2. Assessment of numeric rating scale (NRS) in patients receiving erector spinae plane block during rest and movement during postoperative period at 0, 2, 4, 6, 8, 12,24 hours.

Conditions

  • Postoperative Pain

Interventions

PROCEDURE

Erector spinae plane block

The transducer was placed vertically 3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. Bilateral ultrasound guided erector spinae plane block with 20 mL of 0.375% bupivacaine each using an in-plane, cranial-to-caudad approach to contact the bony shadow of the transverse process (TP) with the tip deep to the fascial plane of the erector spinae muscle. The correct location of the needle tip was confirmed by injecting 0.5-1 cc of normal saline 0.9% and observing linear fluid spread lifting the erector spinae muscle off the tip of the TP.

DEVICE

Intravenous meperidine patient controlled analgesia device

Intravenous meperidine patient controlled analgesia device will be given to the patients postoperatively and 24 hour meperidine consumption will be recorded

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Bassem M EL-Ayashy, Master Degree · Suez Canal University

  • Emad EL-Deen A Ibrahim, Doctor of Medicine · Suez Canal University

  • Hamdy A Hendawy, Doctor of Medicine · Suez Canal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-09-01
Completion
2020-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382209 on ClinicalTrials.gov