Clinical trial NCT04316416: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
erector spinae plane blok
laparoscopic cholecystectomy
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-20
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postoperative pain change
timeFrame: up to 24 hours
measure: Postoperative morphine consumption change
timeFrame: up to 24 hours
Secondary outcomes:
measure: side effects
timeFrame: up to 24 hours
measure: number of blocked dermatome sites
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: SERPİL SEHİRLİOGLU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: AYFER KAYA GOK, MD
role: STUDY_CHAIR
affiliation: Gaziosmanpasa Research and Education Hospital
name: UMRAN YAMAN, MD
role: STUDY_CHAIR
affiliation: Gaziosmanpasa Research and Education Hospital
name: AYGEN U TURKMEN, MD
role: STUDY_CHAIR
References:
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.