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Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
T7 Level Erector Spinae Plane Block
T9 Level Erector Spinae Plane Block
control group
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring postoperative pain, erector spinae plane blok, laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA 1-2 Elective cholecystectomy surgery
  • 18-65 years old patients

Exclusion Criteria:

  • 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

Sites / Locations

  • Gaziosmanpasa Research and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

T7 Bilateral ESP block

T9 bilateral ESP block

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

side effects
Rate of side-effect occurrences (such as rate of vomiting,nausea,shoulder pain) between groups will be compared.
number of blocked dermatome sites
number of blocked dermatome sites will be recorded.

Full Information

First Posted
March 8, 2020
Last Updated
June 2, 2020
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04316416
Brief Title
Evaluation of Effectivity of Erector Spina Plane Block With Different Levels
Official Title
Evaluation of The Postoperative Analgesic Effectivity of Erector Spina Plane Block With Different Injection Levels on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
June 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, erector spinae plane blok, laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T7 Bilateral ESP block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
T9 bilateral ESP block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
T7 Level Erector Spinae Plane Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
T9 Level Erector Spinae Plane Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
control group
Intervention Description
24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.
Primary Outcome Measure Information:
Title
Postoperative pain change
Description
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.
Time Frame
up to 24 hours
Title
Postoperative morphine consumption change
Description
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.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
side effects
Description
Rate of side-effect occurrences (such as rate of vomiting,nausea,shoulder pain) between groups will be compared.
Time Frame
up to 24 hours
Title
number of blocked dermatome sites
Description
number of blocked dermatome sites will be recorded.
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA 1-2 Elective cholecystectomy surgery 18-65 years old patients Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SERPİL SEHİRLİOGLU, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AYFER KAYA GOK, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
UMRAN YAMAN, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
AYGEN U TURKMEN, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Gaziosmanpasa Research and Education Hospital
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31822353
Citation
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.
Results Reference
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Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

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