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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03869801
Other study ID # ESP vs QLB in LC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2019
Est. completion date May 31, 2019

Study information

Verified date May 2019
Source Maltepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Quadratus Lumborum block (QLB) type 2 is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and QLB in laparoscopic cholecystectomy.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Elective laparoscopic Cholecystectomy, ASA status 1-2

Exclusion Criteria:

- Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae plane block
Ultrasound-guided bilateral Erector spinae plane (ESP) block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
quadratus lumborum block
Ultrasound-guided bilateral Quadratus lumborum (QLB) type 2 block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.

Locations

Country Name City State
Turkey Antalya research hospital Antalya
Turkey Maltepe University faculty of medicine Istanbul
Turkey Cigli Educatinal Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ökmen K, Metin Ökmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.0 — View Citation

Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary analgesic consumption opioid consumption in Patient Controlled Analgesia device 24 hours
Secondary NRS scores Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). 24 hours
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