Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

NCT04316416 | Completed DMC

• 1 other identifier: GaziosmanpasaTREH18
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.

Conditions

Postoperative Pain

Keywords

postoperative pain; erector spinae plane blok; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Postoperative pain change

  It was planned to check the change in the NRS scores of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels. A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.

  up to 24 hours

• Postoperative morphine consumption change

  It was planned to check the change in the morphine consumption of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.

  up to 24 hours

Secondary Outcomes (2)

• side effects

  up to 24 hours

• number of blocked dermatome sites

  up to 24 hours

Study Arms (3)

T7 Bilateral ESP block

ACTIVE COMPARATOR

Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging T7 (7th thoracal vertebrae ) transverse process accompanied by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed.

Procedure: T7 Level Erector Spinae Plane Block

T9 bilateral ESP block

ACTIVE COMPARATOR

Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging transverse process T9 (9th thoracal vertebrae) by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed.

Procedure: T9 Level Erector Spinae Plane Block

Control group

PLACEBO COMPARATOR

Postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard pain follow-up and monitorization will be performed. No block will be performed in this group.

Drug: control group

Interventions

T7 Level Erector Spinae Plane Block PROCEDURE

ESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T7 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T7 spinous process. After imaging of erector spina musceles and transvers process of 7 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge \& 8cm directed from cranial to caudal. After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them. Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded.

T7 Bilateral ESP block

T9 Level Erector Spinae Plane Block PROCEDURE

ESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T9 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T9 spinous process. After imaging of erector spina musceles and transvers process of 9 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge \& 8cm directed from cranial to caudal. After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them. Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded.

T9 bilateral ESP block

control group DRUG

24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.

Control group

Eligibility Criteria

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

You may qualify if:

• ASA 1-2 Elective cholecystectomy surgery
• years old patients

You may not qualify if:

• ASA 3-4 patients
• Patient refusal
• several lung and heart disease
• Contraindications to regional anesthesia
• BMİ \> 35 patients
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Severe kidney or liver disease
• Patient with psychiatric disorders

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Altiparmak B, Toker MK, Uysal AI, Kuscu Y, Demirbilek SG. [Efficacy of ultrasound-guided erector spinae plane block for analgesia after laparoscopic cholecystectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):561-568. doi: 10.1016/j.bjan.2019.09.001. Epub 2019 Dec 9.

  PMID: 31822353 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• SERPİL SEHİRLİOGLU, MD

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

• AYFER KAYA GOK, MD

  Gaziosmanpasa Research and Education Hospital

  STUDY CHAIR

• UMRAN YAMAN, MD

  Gaziosmanpasa Research and Education Hospital

  STUDY CHAIR

• AYGEN U TURKMEN, MD

  Gaziosmanpasa Research and Education Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 20, 2020
• Study Start: February 15, 2020
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)