Clinical trial NCT06664164: Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Inguinal Hernia Surgery
Official title: Comparison of Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Technique Inguinal Hernia Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Keywords: anterior quadratus lumborum block
postoperative pain
adjuvant
dexamethasone
inguinal hernia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-29
Enrollment: 50
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: Evaluation of Postoperative Analgesic Efficacy of Adjuvant Use in Quadratus Lumborum Blocks

Detailed description: primary aim is to compare and evaluate the total analgesic consumption 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.

secondary aims are to:

Compare the time to first rescue analgesia in patients. Compare NRS (Numerical Rating Scale) values (at rest and dynamic) in patients during postoperative follow-ups at 2, 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.

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 Opioid Consumption
timeFrame: 24 hour
Secondary outcomes:
measure: To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
timeFrame: 24 hour
measure: time to first rescue analgesic requirement.
timeFrame: 24 hour
measure: To compare postoperative side effects such as nausea, vomiting, and itching.
timeFrame: 24 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Training Hospital
Study officials:
affiliation: Gaziosmanpasa Research and Training Hospital
name: Serpil Sehirlioglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.