The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

NCT03815799 | Completed

• 1 other identifier: ESP-RF
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy; Postoperative Pain; Respiratory Function

Keywords

Erector Spinae Block; Laparoscopy; Respiratory Function

Outcome Measures

Primary Outcomes (1)

• Scoring of postoperative pain

  The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).

  Postoperative 24 hour

Secondary Outcomes (3)

• Analgesic consumption

  Postoperative 24 hour

• Spirometric Parameters of Respiratory Functions

  Preoperative (before the surgery) and at postoperative 24th hour

• Number of Adverse events

  Postoperative 24 hour

Study Arms (2)

Erector Spinae Plane Block Group

EXPERIMENTAL

Procedure: In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions.

Procedure: Bilateral Erector Spinae Block

Control

SHAM COMPARATOR

Routine standard perioperative and postoperative analgesic protocol will be given.

Other: Control

Interventions

Bilateral Erector Spinae Block PROCEDURE

A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).

Erector Spinae Plane Block Group

Control OTHER

Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy

You may not qualify if:

• Patients refusal
• Contraindications for regional anesthesia
• Alcohol or drug abuse
• Chronic opioid intake
• Patient with psychiatric disorders
• Use of pain killers within the 24 h before the operation
• Respiratory tract infection within the last 2 weeks
• Smoker or history of smoking
• Allergy to local anesthetics
• Respiratory and allergic diseases
• Cardiac disease associated with dyspnea

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

Location

Related Publications (3)

• 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

• Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.

  PMID: 25948166 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

MeSH Terms

Conditions

Pain, Postoperative; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 24, 2019
• Study Start: March 3, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)