- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664164
Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Inguinal Hernia Surgery
Comparison of Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Technique Inguinal Hernia Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
primary aim : Compare the time to first rescue analgesia in patients following the application of non-adjuvant Quadratus Lumborum Block and adjuvant Quadratus Lumborum Block for postoperative analgesia after inguinal hernia surgeries performed under spinal anesthesia.
secondary aims are to: to compare and evaluate the total analgesic consumption over 24 hours Compare NRS (Numerical Rating Scale) values (at rest and dynamic) in patients during postoperative follow-ups at 4, 8, 12, and 24 hours.
Compare side effects such as postoperative nausea and vomiting. In trunk blocks, local anesthesia is applied to the interfascial area between the abdominal wall or back muscles. Local anesthetics and steroids are used for this purpose. The analgesic efficacy of steroids is known from their perineural applications. Due to the lack of blood circulation and vascularization in the interfascial area, the absorption of local anesthetics is slow, providing prolonged analgesic effects. Trunk blocks applied in these regions are used as part of multimodal analgesia. The effectiveness of trunk blocks may vary based on the patient's anatomical differences and previous surgeries, but analgesic efficacy is generally observed for an average of 8-12 hours. the investigators believe that with the use of adjuvants, these durations will be extended, and analgesic efficacy will increase.
In this study, it is planned to add a total of 8 mg of dexamethasone to the local anesthetic agent for patients undergoing adjuvant anterior Quadratus Lumborum Block. In studies conducted in the field of trunk blocks, the expected duration of analgesia is an average of 8-12 hours. In this study, the block application is planned to be preoperative. Dexamethasone was chosen as an adjuvant to extend the expected analgesia duration of 8-12 hours and to increase analgesic efficacy. Dexamethasone is known to be effective and safe when used as an adjuvant in all nerve blocks.
To reduce opioid-related side effects such as nausea, vomiting, itching, constipation, and dependence associated with opioid medications used in postoperative analgesia for inguinal hernia surgeries, opioid-sparing analgesia and regional techniques are being employed. Quadratus Lumborum Blocks are being safely and easily performed and are frequently preferred in abdominal surgery due to recent advancements in trunk block techniques and ultrasound technology.
This study aims to evaluate the postoperative analgesic efficacy of adjuvant and non-adjuvant anterior Quadratus Lumborum Blocks in patients undergoing inguinal hernia surgery. The investigators predict that the analgesic efficacy of the adjuvant Quadratus Lumborum Block will be more effective and longer-lasting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34255
- Gaziosmanpasa Research and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: QLB Group
anterior quadratus lumborum block group
|
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.
|
|
Active Comparator: adjuvant QLB Group
with adjuvant anterior quadratus lumborum block group
|
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 8 mg de-xamethasone are injected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to first rescue analgesic requirement.
Time Frame: 24 hour
|
Compare the time to first rescue analgesia in patients
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total analgesic Consumption
Time Frame: 24 hour
|
Our primary aim is to compare and evaluate the total analgesic consumption(diclofenac) over 24 hours following the application of non-adjuvant Quadratus Lumborum Block and adjuvant Quadratus Lumborum Block for postoperative analgesia after inguinal hernia surgeries performed under spinal anesthesia.
|
24 hour
|
|
To compare the NRS (Numering rating scale) values (resting and dynamic) at 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
Time Frame: 24 hour
|
Compare NRS (Numerical Rating Scale) values (at rest and dynamic) in patients during .
postoperative follow-ups at 4, 8, 12, and 24 hoursAssessed at various time points to quantify pain intensity at rest and during movement.
The Numerical Rating Scale (NRS) is a pain assessment tool where patients rate their pain from 0 (no pain) to 10 (worst pain).
|
24 hour
|
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To compare postoperative side effects such as nausea, vomiting
Time Frame: 24 hour
|
To compare postoperative side effects such as nausea, vomiting, quadriceps weakness
|
24 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Serpil Sehirlioglu, MD, Gaziosmanpasa Research and Training Hospital
Publications and helpful links
General Publications
- Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.
- Priyadarshini K, Behera BK, Tripathy BB, Misra S. Ultrasound-guided transverse abdominis plane block, ilioinguinal/iliohypogastric nerve block, and quadratus lumborum block for elective open inguinal hernia repair in children: a randomized controlled trial. Reg Anesth Pain Med. 2022 Apr;47(4):217-221. doi: 10.1136/rapm-2021-103201. Epub 2022 Jan 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Anatomical
- Hernia
- Hernia, Abdominal
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Hernia, Inguinal
- Pharmaceutical Preparations
- Chemical Actions and Uses
- Specialty Uses of Chemicals
- Pharmaceutic Aids
- Adjuvants, Pharmaceutic
Other Study ID Numbers
- GAZIAOSMANPASA TREHAQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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