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 | Unknown

• 1 other identifier: ESPB for postoperative pain
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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:
• 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.
• 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

Keywords

Erector spinae plane block; Postoperative pain; Bupivacaine; Major abdominal surgeries; Meperidine; Intravenous patient controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Meperidine consumptions for both group will be recorded

  24 hours after surgery

Secondary Outcomes (1)

• Numeric rating scale (NRS)

  24 hours after surgery

Study Arms (2)

Erector Spinae plane block group

ACTIVE COMPARATOR

Erector spinae plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively.

Procedure: Erector spinae plane block

Control group

SHAM COMPARATOR

An intravenous patient controlled analgesia device will be given to the patients postoperatively

Device: Intravenous meperidine patient controlled analgesia device

Interventions

Erector spinae plane block PROCEDURE

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.

Erector Spinae plane block group

Intravenous meperidine patient controlled analgesia device DEVICE

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

Control group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 21 - 60 years
• Patients undergoing major abdominal surgery:
• The indication for operation may be for benign or malignant disease.
• Major surgery is defined as an operation of anticipated duration of more than one hour.

You may not qualify if:

• Patients with history of bleeding diathesis or on anticoagulant.
• Patients with relevant drug allergy.
• Patients with psychiatric illnesses, opioid dependence; alcohol or drug abuse that would interfere with perception and assessment of pain were excluded from the study.
• Compensated or decompensated myocardial insufficiency.
• Decreased renal function (serum creatinine \<2.0 mg/dL).
• Infection of the skin at the site of needle puncture area

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal Teaching Hospital, Faculty of Medicine, Suez Canal University

Ismailia, 41522, Egypt

Location

Related Publications (5)

• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

  PMID: 28252539 BACKGROUND

• Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

  PMID: 28272292 BACKGROUND

• Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

  PMID: 18428988 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bassem M EL-Ayashy, Master Degree

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Emad EL-Deen A Ibrahim, Doctor of Medicine

  Suez Canal University

  STUDY DIRECTOR

• Hamdy A Hendawy, Doctor of Medicine

  Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)