Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316416
• Other study ID #: GaziosmanpasaTREH18
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: June 2, 2020

Study information

• Verified date: June 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

• BMI > 35 patients

• Known allergy to local anesthetics

• Bleeding diathesis

• Use of any anti-coagulants

• Severe kidney or liver disease

• Patient with psychiatric disorders

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Drug:
• control group
24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Research and Education Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Altiparmak B, Toker MK, Uysal AI, Kusçu Y, Demirbilek SG. [Efficacy of ultrasound-guided erector spinae plane block for analgesia after laparoscopic cholecystectomy: a randomized controlled trial]. Rev Bras Anestesiol. 2019 Nov - Dec;69(6):561-568. doi: 10.1016/j.bjan.2019.09.001. Epub 2019 Dec 9. Portuguese. — View Citation

Outcome

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