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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04459624
Other study ID # ESOGU 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date January 31, 2022

Study information

Verified date February 2022
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. It is associated with postoperative morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional analgesia consumption, patient and surgeon satisfaction.


Description:

At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, initial analgesic requirement, nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon satisfaction, and postoperative complications will be recorded.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 31, 2022
Est. primary completion date July 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Partial or radical nephrectomy - American Society of Anesthesiologist physical status I-III Exclusion Criteria: - Infection in the incision area - Coagulation disorder - Known allergy history against to the study drugs - Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector Spina Plane Block
Group E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
Quadratus Lumborum Block 2
Group Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.

Locations

Country Name City State
Turkey Eskisehir Osmangazi Univercity Odunpazari Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Aksu C, Sen MC, Akay MA, Baydemir C, Gürkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6. — View Citation

Öksüz G, Bilal B, Gürkan Y, Urfalioglu A, Arslan M, Gisi G, Öksüz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645. — View Citation

Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3. Review. — View Citation

Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 10.4103/aer.AER_108_18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain)) 24 hours
Secondary Total opiate consumption Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours 24 hours
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