Clinical trial NCT05943015: Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
Official title: Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral Blocks in Elective Laparoscopic Cholecystectomies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: paravertebral block
quadratus lumborum block
laparoscopic cholecystectomy
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective 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 block and paravertebral plane blocks are regional techniques performed for multimodal analgesia.

The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.

Eligibility criteria: Inclusion Criteria:

* 18-65 years, 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

Primary outcomes:
measure: Total amount of tramadol use
timeFrame: within 24 hours after the surgery
Secondary outcomes:
measure: Visual Analogue Scale values at 1st, 6th, 12th and 24th hours
timeFrame: at 1st, 6th, 12th and 24th hours after the surgery
measure: Block onset time
timeFrame: 30 min after the block
measure: intraoperative remifentanil consumption
timeFrame: during operation procedure
measure: postoperative length of hospital stay
timeFrame: within 1 weeks after the surgery
measure: side effects such as nausea, vomiting and shoulder pain
timeFrame: within 24 hours after the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Resarch and Education Hospital
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: EMINE KOSE
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: DONDU GENC MORALAR
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: SERPIL SAHIN SEHIRLIOGLU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, Cui X, Ren L, Li X, Zhang Y, Xie Y, Ji Z, Huang Y. Comparison of the Postoperative Analgesic Effects between Ultrasound-Guided Transmuscular Quadratus Lumborum Block and Thoracic Paravertebral Block in Laparoscopic Partial Nephrectomy Patients: A Randomized, Controlled, and Noninferiority Study. Pain Res Manag. 2023 Feb 20;2023:8652596. doi: 10.1155/2023/8652596. eCollection 2023.