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Clinical Trials/NCT07676123
NCT07676123Active, not recruitingNot Applicable

COMPARISON OF THE EFFECTS OF QUADRATUS LUMBORUM BLOCK AND ILIOINGUINAL-ILIOHYPOGASTRIC NERVE BLOCK ON INTRAOPERATIVE OPIOID CONSUMPTION GUIDED BY NOCICEPTION INDEX, POSTOPERATIVE ACUTE PAIN, AND CHRONIC PAIN IN LAPAROSCOPIC INGUINAL HERNIA REPAIR

Ankara University1 site in 1 country66 target enrollmentStarted: June 26, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
66
Locations
1
Primary Endpoint
Effects of preemptive Quadratus Lumborum Block versus Iliohypogastric-Ilioinguinal nerve block on postoperative analgesic requirements in laparoscopic inguinal hernia repair

Study Overview

Brief Summary

After inguinal hernia repair, patients having chronic pain approximately 20 percent. If patients don't have postoperatively acute pain, they will tend to have less chronic pain. The purpose of study is to make people have less pain, even better not to have any. In this study, patients will have preemptive nerve blockage and by this way, they will have less acute and chronic pain.

Detailed Description

The lifetime incidence of inguinal hernia is 27% in men and 3% in women. The primary treatment is surgical intervention. Postoperative pain is defined as acute pain that begins with surgical trauma and gradually decreases with tissue healing. As with all surgical procedures, the treatment and control of pain following inguinal hernia repair are of great importance. Adequate pain control enables faster recovery, reduces thromboembolic complications through early mobilization, decreases pulmonary complications by preventing restrictions in respiratory movements, sputum expectoration, and cough reflex, minimizes metabolic and endocrine stress responses, preserves cognitive functions, reduces the risk of chronic pain development, and shortens the duration of hospital stay. Preventing acute postoperative pain will also reduce the probability of chronic pain development.

In anesthetized patients, accurate pain assessment is crucial for the anesthesiologist to adjust analgesic drug levels. While adequate analgesic levels are critical to prevent unexpected movements, cardiovascular complications resulting from sympathetic reactions, and the development of pain memory, limiting dosage to the minimum effective level is desirable to avoid opioid-induced hyperalgesia, drug side effects, and to achieve shorter perioperative durations.

It is suggested that intraoperative hemodynamic and stress responses, as well as postoperative chronic pain syndromes, are primarily caused by the poor control of nociceptive conditions. Techniques have been developed for more effective monitoring of the analgesia component of anesthesia to guide the administration of analgesics in order to provide an appropriate balance of nociception and antinociception. Nociception monitoring can be achieved through "central nervous system-based," "autonomic nervous system-based," and "spinal reflex-based" monitors. Autonomic nervous system-based monitors include pupillometry, the Analgesia Nociception Index (ANI), the Surgical Pleth Index, the Nociception Level Index, and skin conductance monitors.

The Analgesia Nociception Index (ANI) monitor is derived from heart rate variability, ranging from 0 (maximal nociception) to 100 (maximal analgesia) to reflect the analgesia/nociception balance during general anesthesia, and it detects changes in sympathovagal balance caused by surgical stimuli in the heart rhythm. Higher ANI values represent higher parasympathetic activity and likely less pain. Pain monitors not only help us avoid unnecessary opioid consumption but also assist in reducing opioid-related side effects such as nausea-vomiting, urinary retention, opioid-induced hyperalgesia, and physical dependence.

The incidence of chronic postoperative pain in patients undergoing inguinal hernia repair has been observed to be approximately 22.3% at the 3rd month. Chronic pain development affects the patients' mood and daily living activities. Although there are many mechanisms in the pathology of chronic pain formation after inguinal hernia surgery, research has shown that the preemptive blockade of the iliohypogastric-ilioinguinal nerves is effective in reducing the incidence of postoperative acute and chronic pain.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Once patients consent to participate, the investigator responsible for randomization will inform the practitioner who will perform the preemptive block regarding the assigned study arm. The anesthesiologist providing intraoperative and postoperative care will be blinded to the type of block performed. At the fourth month postoperatively, patients will be assessed for chronic pain development by an anesthesiologist other than the principal investigators; the randomization code will be unblinded only at the data analysis stage.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who have not undergone previous inguinal hernia surgery
  • Age 18 and over
  • ASA physical status I-III
  • BMI: 18-30 kg/m²
  • No known cognitive impairment
  • Patients who are willing to participate in the study and provide informed consent
  • No history of chronic pain and no chronic analgesic or opioid use

Exclusion Criteria

  • Age under 18
  • ASA physical status IV or higher
  • BMI > 30 kg/m²
  • Presence of any chronic pain
  • Chronic opioid consumption
  • Known cognitive impairment
  • Illiterate
  • Visual or hearing impairment
  • Infection at the injection site
  • Coagulopathy
  • Chronic hepatic or renal failure
  • Peripheral neuropathy
  • Allergy to local anesthetics
  • Cardiac rhythm disorders, central/autonomic nervous system diseases, or presence of a pacemaker
  • Use of medications that affect cardiac autonomic regulation

Outcomes

Primary Outcomes

Effects of preemptive Quadratus Lumborum Block versus Iliohypogastric-Ilioinguinal nerve block on postoperative analgesic requirements in laparoscopic inguinal hernia repair

Time Frame: Starting from the time of block administration through the 24th postoperative hour or hospital discharge

Patients undergoing laparoscopic inguinal hernia repair will receive a preemptive block, either with a Quadratus Lumborum block or an Ilioinguinal-Iliohypogastric nerve block. The duration of postoperative analgesic efficacy between the two groups will be evaluated as the time elapsed from the administration of the block to the first rescue opioid request via the patient-controlled analgesia (PCA) device, and this duration will be recorded.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Süheyla Karadağ Erkoç

Assoc. Prof. Dr.

Ankara University

Study Sites (1)

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