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Clinical Trials/NCT04316416
NCT04316416
Completed
Not Applicable

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

Gaziosmanpasa Research and Education Hospital1 site in 1 country103 target enrollmentFebruary 15, 2020

Overview

Phase
Not Applicable
Intervention
T7 Level Erector Spinae Plane Block
Conditions
Postoperative Pain
Sponsor
Gaziosmanpasa Research and Education Hospital
Enrollment
103
Locations
1
Primary Endpoint
Postoperative pain change
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2020
End Date
June 2, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

SERPİL ŞEHİRLİOĞLU

Attending Anesthesiologist

Gaziosmanpasa Research and Education Hospital

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

Arms & Interventions

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.

Intervention: T7 Level Erector Spinae Plane Block

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.

Intervention: T9 Level Erector Spinae Plane Block

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.

Intervention: control group

Outcomes

Primary Outcomes

Postoperative pain change

Time Frame: up to 24 hours

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

Time Frame: up to 24 hours

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 Outcomes

  • side effects(up to 24 hours)
  • number of blocked dermatome sites(up to 24 hours)

Study Sites (1)

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