Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: T7 Level Erector Spinae Plane Block; Procedure: T9 Level Erector Spinae Plane Block; Drug: control group

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Gaziosmanpasa Research and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T7 Bilateral ESP block; 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; 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.
Active Comparator: T9 bilateral ESP block; 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; 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.
Placebo Comparator: Control group; 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; 24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	Rate of side-effect occurrences (such as rate of vomiting,nausea,shoulder pain) between groups will be compared.	up to 24 hours
number of blocked dermatome sites	number of blocked dermatome sites will be recorded.	up to 24 hours

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: Serpil Sehirlioglu, MD, Gaziosmanpasa Research and Education Hospital; Study Chair: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): June 2, 2020
• Study Completion (Actual): June 2, 2020

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain; laparoscopic cholecystectomy; erector spinae plane blok
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: GaziosmanpasaTREH18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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