Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant

NCT06028061 | Completed DMC

• 1 other identifier: GaziosmanpasaTREHBB
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Total amount of opioid requirements

  The total tramadol use of the patients in 24 hours will be recorded.

  within 24 hours after the surgery

• rescue analgesia

  The rescue analgesia requirement and time of the need of the rescue analgesia requirement

  within 24 hours after the surgery

Secondary Outcomes (3)

• intraoperative remifentanil consumption

  during operation procedure]

• Visual Analogue Scale values

  at 1st, 4th,8th 12th and 24th hours after the surgery]

• side effects such as nausea, vomiting and shoulder pain

  within 24 hours after the surgery

Study Arms (2)

Adjuvant-free Quadratus lumborum block

ACTIVE COMPARATOR

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.

Procedure: Adjuvant-free Quadratus lumborum block

Quadratus Lumborum Block with adjuvant

ACTIVE COMPARATOR

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.

Procedure: Quadratus lumborum block III with Adjuvant

Interventions

Adjuvant-free Quadratus lumborum block PROCEDURE

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.

Also known as: only bupivacain, adjuvan-free

Adjuvant-free Quadratus lumborum block

Quadratus lumborum block III with Adjuvant PROCEDURE

The same block was applied to this group too, 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.

Also known as: bupivacain with dexamethasone

Quadratus Lumborum Block with adjuvant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• years of age
• American Society of Anesthesiologists physical statusⅠ-II
• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, Marmara, 34255, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 35764836 BACKGROUND

• 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.

  PMID: 31862217 BACKGROUND

• 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.

  PMID: 32563073 BACKGROUND

• 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.

  PMID: 36288584 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Adjuvants, Pharmaceutic; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• SERPİL SEHİRLİOGLU, MD

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

• BATUHAN BURHAN, MD

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

• DONDU GENC MORALAR, MD

  Gaziosmanpasa Research and Education Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: February 15, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)