Clinical trial NCT06664177: Analgesic Efficacy of Quadratus Lumborum vs. Transversalis Fascia Block in Laparoscopic Hernia Surgery
Official title: Comparison of the Postoperative Analgesic Efficacy of Quadratus Lumborum Block and Transversalis Fascia Block in Laparoscopic Inguinal Hernia Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Keywords: quadratus lumborum block
Transversalis Fascia Plane Block
dermatomal distribution
inguinal hernia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is planned to compare the postoperative analgesic efficacy of the Transversalis Fascia Plane Block and the anterior Quadratus Lumborum Block in elective laparoscopic inguinal hernia surgeries.

Detailed description: It is planned to compare the postoperative analgesic efficacy of the Transversalis Fascia Plane Block and the anterior Quadratus Lumborum Block in elective laparoscopic inguinal hernia surgeries.

Primary Objective: Our primary aim is to compare and evaluate the time to first rescue analgesic requirement after the application of anterior Quadratus Lumborum Block and Transversalis Fascia Plane Block in patients undergoing elective laparoscopic inguinal hernia surgeries under general anesthesia.

Secondary Objectives:

To compare the total analgesic consumption in the first 24 hours postoperatively.

To compare the Numeric Rating Scale (NRS) values (at rest and dynamic) of patients at postoperative follow-ups at 2, 4, 8, 12, and 24 hours.

To compare postoperative side effects such as nausea and vomiting. In trunk blocks, local anesthetic is applied to the interfascial area between the anterior abdominal wall or back muscles. Due to the lack of blood circulation and vascularization in the interfascial area, the absorption of local anesthetics is slow, allowing for prolonged analgesic effects. For this reason, trunk blocks are used as part of multimodal analgesia. The effectiveness of trunk blocks can vary based on the patient's structural anatomical differences and previous surgeries, but an average analgesic effect of 8-12 hours is typically observed. Sometimes, analgesic effects have been reported to last up to 24 hours.

Pain that arises from elective laparoscopic inguinal hernia surgeries can negatively impact postoperative immobilization, atelectasis, pneumonia due to atelectasis, and prolonged hospital stays. Due to the side effects associated with opioid medications used for postoperative analgesia, such as nausea, vomiting, itching, constipation, and dependency, non-opioid analgesic medications and regional techniques are used as part of multimodal analgesia to reduce opioid use.

Quadratus Lumborum and Transversalis Fascia Blocks can be safely and easily performed, especially in lower abdominal surgery, due to advancements in trunk blocks and ultrasound technology in recent years.

This study aims to evaluate the postoperative analgesic efficacy of Quadratus Lumborum Blocks and Transversalis Fascia Blocks administered to patients undergoing elective laparoscopic inguinal hernia surgery. The Transversalis Fascia Block can be utilized in lower abdominal surgeries by blocking the ilioinguinal, iliohypogastric nerves, and the T12 intercostal nerve. The Quadratus Lumborum Block provides analgesic efficacy in the T7-L2 dermatomal area.In patients planned for elective laparoscopic inguinal hernia surgery, informed consent was obtained after detailed information was provided. The patients were randomly divided into two groups using closed envelope randomization: the anterior Quadratus Lumborum Block group and the Transversalis Fascia Block group.

All patients will be taken to the block room 30 minutes before the surgery. All blocks will be performed under ultrasound guidance by the same anesthesia specialist while the patients are in the lateral decubitus position, with the surgical sites facing up.

In the Quadratus Lumborum block group, in the lateral decubitus position, a convex ultrasound probe will be sterilely placed in the subcostal area and above the iliac crest. The quadratus lumborum and psoas major muscles, as well as the L4 vertebra's transverse process, will be visualized. Using the in-plane technique and a 22G 100 mm peripheral block needle, the placement will first be identified through hydrodissection in the subfascial area between the quadratus lumborum and psoas major muscles. After localization, 20 mL of 0.5% bupivacaine will be injected slowly, aspirating every 5 cc, while visualizing the local anesthetic pushing the fascia in the ultrasound image.

In the Transversalis Fascia Block group, the same procedure will be followed as in the Quadratus Lumborum block group, with the ultrasound probe being placed in the same location, and the same in-plane technique will be applied with a 22G 100 mm peripheral block needle. After hydrodissection, 20 mL of 0.5% bupivacaine will be injected slowly in the same manner.

All patients will be monitored for 30 minutes in the block room after the block application. The dermatomal areas will be tested with a cold ice pack and recorded at 20 and 30 minutes. After the dermatomal analyses at 30 minutes, the patients will be taken to the operating room.

All patients will receive anesthesia using the same technique under general anesthesia before surgery. At the end of the operation, all patients will receive intravenous 1g of paracetamol for postoperative analgesia. Routine extubation will be performed, and patients will be sent to the ward after recovery.

Postoperative analgesia for patients was planned as paracetamol 4x1g. Patients will be followed up by a different blinded anesthesia assistant from the one who performed the block at 2, 4, 8, 12, and 24 hours. The first rescue analgesia times, NRS scores (evaluated on a scale of 1 to 10, where 0 means no pain and 10 means very severe pain), postoperative side effects, and total analgesic amounts used in 24 hours will be recorded.

In postoperative follow-ups, for patients with NRS scores greater than 3, intravenous ibuprofen will be planned as rescue analgesia in the ward. If pain does not resolve within 30 minutes, tramadol hydrochloride 1 mg/kg IV will be planned.

In trunk blocks, blocking the thoracoabdominal nerves that travel between the fascia with local anesthetics is thought to provide analgesia during the postoperative period, increasing patient comfort, reducing postoperative opioid consumption and dependency, facilitating early mobilization, shortening the hospital stay, and minimizing opioid side effects.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* ASA Classification 1-2

Exclusion Criteria:

* Allergy to local anesthetics
* Presence of infection at the procedure site
* BMI \> 35 kg/m²
* Bleeding disorders or anticoagulant use
* Chronic analgesic or opioid use
* Mental or psychiatric disorders
* ASA Classification 3-4 patients(Severe COPD, history of cerebrovascular events, liver and kidney disease will be excluded from the study.)

Primary outcomes:
measure: time to first rescue analgesic requirement.
timeFrame: 24 hour
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: 24 hour
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
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Resource and Training Hospital
Study officials:
References:
citation: Abdelbaser I, Mageed NA, El-Emam EM, ALseoudy MM, Elmorsy MM. Preemptive analgesic efficacy of ultrasound-guided transversalis fascia plane block in children undergoing inguinal herniorrhaphy: a randomized, double-blind, controlled study. Korean J Anesthesiol. 2021 Aug;74(4):325-332. doi: 10.4097/kja.20601. Epub 2020 Dec 14.
citation: Samerchua A, Leurcharusmee P, Panichpichate K, Bunchungmongkol N, Wanvoharn M, Tepmalai K, Khorana J, Chantakhow S. A Prospective, randomized comparative study between ultrasound-guided posterior quadratus lumborum block and ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric inguinal herniotomy. Paediatr Anaesth. 2020 Apr;30(4):498-505. doi: 10.1111/pan.13837. Epub 2020 Feb 21.
citation: Ahmed A, Fawzy M, Nasr MAR, Hussam AM, Fouad E, Aboeldahb H, Saad D, Osman S, Fahmy RS, Farid M, Waheb MM. Ultrasound-guided quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia repair, a comparative study between two approaches. BMC Anesthesiol. 2019 Oct 17;19(1):184. doi: 10.1186/s12871-019-0862-z.