Clinical trial NCT06028061: Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant
Official title: Evaluation of The Postoperative Analgesic Effectivity of Quadratus Lumborum Block III With Adjuvant on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Management
Postoperative Pain
Analgesia
Nerve Blocks
Nerve Block Duration
Cholecystectomy
Keywords: postoperative pain
laparoscopic cholecystectomy
quadratus lumborum block
abdominal wall blocks
adjuvant
dexamethasone
postoperative analgesia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-07
Enrollment: 83
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: İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at patient underwent laparoscopic cholecystectomy.

Detailed description: Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for patients who underwent laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria: American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* Inclusion Criteria:
* 18-65 years of age
* American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* local anesthetic allergy
* Infection at the procedure site Body Mass Index \>35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease

Primary outcomes:
measure: Total amount of opioid requirements
timeFrame: within 24 hours after the surgery
measure: rescue analgesia
timeFrame: within 24 hours after the surgery
Secondary outcomes:
measure: intraoperative remifentanil consumption
timeFrame: during operation procedure]
measure: Visual Analogue Scale values
timeFrame: at 1st, 4th,8th 12th and 24th hours after the surgery]
measure: side effects such as nausea, vomiting and shoulder pain
timeFrame: within 24 hours after the surgery
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
state: Marmara
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: SERPİL SEHİRLİOGLU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: BATUHAN BURHAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: DONDU GENC MORALAR, MD
role: STUDY_DIRECTOR
References:
citation: Zhang Y, Wang YP, Wang HT, Xu YC, Lv HM, Yu Y, Wang P, Pei XD, Zhao JW, Nan ZH, Yang JJ. Ultrasound-guided quadratus lumborum block provided more effective analgesia for children undergoing lower abdominal laparoscopic surgery: a randomized clinical trial. Surg Endosc. 2022 Dec;36(12):9046-9053. doi: 10.1007/s00464-022-09370-z. Epub 2022 Jun 28.
citation: Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.
citation: Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.
citation: Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.