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Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant (AdjuvantQLB)

Primary Purpose

Postoperative Pain Management, Postoperative Pain, Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadratus Lumborum Block III
Quadratus lumborum block III with Adjuvant
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain Management focused on measuring postoperative pain, laparoscopic cholecystectomy, quadratus lumborum block, abdominal wall blocks, adjuvant, dexamethasone, postoperative analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gaziosmanpasa Research and Education HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus lumborum block

Quadratus Lumborum Block with adjuvant

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

intraoperative remifentanil consumption
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.
Visual Analogue Scale values
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.
side effects such as nausea, vomiting and shoulder pain
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06028061
Brief Title
Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant
Acronym
AdjuvantQLB
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quadratus lumborum block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quadratus Lumborum Block with adjuvant
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Block III
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block III with Adjuvant
Intervention Description
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 Measure Information:
Title
Total amount of opioid requirements
Description
The total tramadol use of the patients in 24 hours will be recorded.
Time Frame
within 24 hours after the surgery
Title
rescue analgesia
Description
The rescue analgesia requirement and time of the need of the rescue analgesia requirement
Time Frame
within 24 hours after the surgery
Secondary Outcome Measure Information:
Title
intraoperative remifentanil consumption
Description
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.
Time Frame
during operation procedure]
Title
Visual Analogue Scale values
Description
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.
Time Frame
at 1st, 4th,8th 12th and 24th hours after the surgery]
Title
side effects such as nausea, vomiting and shoulder pain
Description
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.
Time Frame
within 24 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serpil SEHİRLİOGLU, MD
Phone
+905054431852
Email
drserpilsahin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Batuhan BURHAN, MD
Phone
+905398740609
Email
fenerlibatuhan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SERPİL SEHİRLİOGLU, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BATUHAN BURHAN, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DONDU GENC MORALAR, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gaziosmanpasa Research and Education Hospital
City
İ̇stanbul
State/Province
Marmara
ZIP/Postal Code
34255
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SERPİL SEHİRLİOGLU, MD
Phone
34255
Email
drserpilsahin@gmail.com
First Name & Middle Initial & Last Name & Degree
BATUHAN BURHAN, MD
Email
fenerlibatuhan@gmail.com
First Name & Middle Initial & Last Name & Degree
SERPİL SEHİRLİOGLU, MD
First Name & Middle Initial & Last Name & Degree
BATUHAN BURHAN, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35764836
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.
Results Reference
background
PubMed Identifier
31862217
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.
Results Reference
background
PubMed Identifier
32563073
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.
Results Reference
background
PubMed Identifier
36288584
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.
Results Reference
background

Learn more about this trial

Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant

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