Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant

Not Applicable

Completed

• Conditions: Postoperative Pain Management; Nerve Block Duration; Analgesia; Postoperative Pain; Nerve Blocks; Cholecystectomy
• Interventions: Procedure: Adjuvant-free Quadratus lumborum block; Procedure: Quadratus lumborum block III with Adjuvant

• Registration Number: NCT06028061
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study Start: 2023-09-01
• Study First Posted: 2023-09-07
• Primary Completion: 2023-12-15
• Study Completion: 2024-02-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant-free Quadratus lumborum block	Adjuvant-free Quadratus lumborum block	Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Quadratus Lumborum Block with adjuvant	Quadratus lumborum block III with Adjuvant	The same block was applied to this group, but a different local anesthetic mixture was used. Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.

Primary Outcome Measures

Name	Time	Method
Total amount of opioid requirements	within 24 hours after the surgery	The total tramadol use of the patients in 24 hours will be recorded.
rescue analgesia	within 24 hours after the surgery	The rescue analgesia requirement and time of the need of the rescue analgesia requirement

Secondary Outcome Measures

Name	Time	Method
intraoperative remifentanil consumption	during operation procedure]	The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
side effects such as nausea, vomiting and shoulder pain	within 24 hours after the surgery	The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.
Visual Analogue Scale values	at 1st, 4th,8th 12th and 24th hours after the surgery]	Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.

Trial Locations

Locations (1)

Gaziosmanpasa Research and Education Hospital; 🇹🇷 İ̇stanbul, Marmara, Turkey