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Completed

NCT Number: NCT06502223

Impact of Gut Microbiota and Tryptophan Metabolites on Acute Pain in Lumbar Disc Herniation Surgery Patients

It is well-established that the gut microbiota plays a crucial role in various pain mechanisms, including visceral pain, inflammatory pain, headache, neuropathic pain, and opioid tolerance. Changes in the gut microbiome can alter pain perception. In our study, The investigator investigated the effects of microbiota alterations and the associated tryptophan metabolites on acute pain using the Visual Analog Scale (VAS).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yunu Çelik

Izmir, Balçova, 35100, Turkey (Türkiye)

About this study

The study included patients aged 18 and above undergoing lumbar disc herniation surgery. Blood samples were collected preoperatively, at 8 hours, and at 24 hours postoperatively to analyze tryptophan metabolites (picolinic acid, 3- Hydroxykynurenine, anthranilic acid, kynurenine, quinolinic acid, kynurenic acid, xanthurenic acid). Concurrent VAS pain assessments were conducted, and correlations between tryptophan metabolites and VAS were evaluated.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing lumbar disc herniation surgery at Dokuz Eylül University Hospital.
  • Patients who have read and consented to the informed consent form for the study.
  • Age 18 years or older.
  • Surgery duration exceeding 2 hours.

Exclusion criteria

  • Patients are unwilling to participate in the study.
  • Surgery duration less than 2 hours.
  • Patients under the age of 18.
  • Patients with a history of abdominal surgery.
  • Patients who received antibiotic therapy for intestinal pathology within the last 3 weeks.
  • Patients with known abdominal pathologies suspected to alter the microbial flora (e.g., Crohn's disease, ulcerative colitis, celiac disease).

Treatment and study plan

Pain Perception in Patients Undergoing Lumbar Disc Herniation Surgery

Procedure

Analyze tryptophan metabolites (picolinic acid, 3- Hydroxykynurenine, anthranilic acid, kynurenine, quinolinic acid, kynurenic acid, xanthurenic acid). Concurrent VAS pain assessments were conducted, and correlations between tryptophan metabolites and VAS were evaluated.

Other names: Microbiota and Associated Blood Tryptophan Metabolites on

Primary outcomes

  1. Tryptophan metabolites (Picolinic Acid)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between picolinic acid and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative, 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. After the necessary centrifugation processes, the relevant laboratory team analyzed the picolinic acid levels (ng/mL).

  2. Tryptophan metabolites (3-Hydroxykynurenine)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between 3-Hydroxykynurenine and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. After the necessary centrifugation processes, the relevant laboratory team analyzed the 3-Hydroxykynurenine levels(ng/mL).

  3. Tryptophan metabolites (Anthranilic Acid)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between anthranilic acid and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative, 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. The relevant laboratory team measured the anthranilic acid levels (ng/mL) following the required centrifugation procedures.

  4. Tryptophan metabolites (Kynurenine)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between kynurenine and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative, 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. After the necessary centrifugation processes, the relevant laboratory team analyzed the kynurenine levels (ng/mL).

  5. Tryptophan metabolites (Quinolinic Acid)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between quinolinic acid and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative, 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. After the necessary centrifugation processes, the relevant laboratory team analyzed the quinolinic acid levels (ng/mL).

  6. Tryptophan metabolites (Kynurenic Acid)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between kynurenic acid and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative, 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. After the necessary centrifugation processes, the relevant laboratory team analyzed the kynurenic acid levels (ng/mL).

  7. Tryptophan metabolites (Xanthurenic Acid)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    2 mL of blood was used from the blood samples taken during routine surgery preparation for the patients and from the routine blood samples taken in the postoperative period, and no additional invasive intervention was performed. The investigator elucidated the relationship between xanthurenic acid and its variations due to microbiota alterations with VAS in acute pain. Preoperative, postoperative, 8th-hour, and 24th-hour blood samples were routinely collected from patients, with 2 mL of sample material used each time. After the necessary centrifugation processes, the relevant laboratory team analyzed the xanthurenic acid levels (ng/mL).

  8. Visual Analog Scale

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    In VAS assessment, patients are typically asked to choose a value between "0, no pain" and "10, the worst imaginable pain." VAS is an 11-point scale (ranging from 0 to 10) that allows patients to numerically express the intensity of their pain. Blood samples were planned and collected from patients during the preoperative evaluation, at the 8th postoperative hour, and at the 24th postoperative hour, adhering to clinical routines for these procedures. Concurrently with each blood draw, the patient's VAS score, the nature of the pain, and vital signs were recorded.

Secondary outcomes

  1. Systolic Blood Pressure (mmHg)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    The study measured the systolic blood pressure (mmHg) of patients at specified time points.The patients' systolic blood pressure data were recorded simultaneously with the blood samples taken during routine surgery preparation and at the 8th and 24th hours postoperatively.

  2. Diastolic Blood Pressure (mmHg)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    The study measured the diastolic blood pressure (mmHg) of patients at specified time points.The patients' diastolic blood pressure data were recorded simultaneously with the blood samples taken during routine surgery preparation and at the 8th and 24th hours postoperatively.

  3. Pulse Rate (beats per minute)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    The study measured patients' pulse rate (beats per minute) at specified time points.The patients' pulse data were recorded simultaneously with the blood samples taken during routine surgery preparation and at the 8th and 24th hours postoperatively.

  4. Respiratory Rate (breaths per minute)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    The study measured the respiratory rate (breaths per minute) of patients at specified time points.

    The patients' respiratory rate data were recorded simultaneously with the blood samples taken during routine surgery preparation and at the 8th and 24th hours postoperatively.

  5. Oxygen Saturation (%)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    The study measured patients' oxygen saturation (%) at specified time points.The patients' oxygen saturation data were recorded simultaneously with the blood samples taken during routine surgery preparation and at the 8th and 24th hours postoperatively.

  6. Nature of Postoperative Pain Assessed by the McGill Pain Questionnaire (MPQ)

    Time frame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery

    The McGill Pain Questionnaire (MPQ) was used to evaluate and categorize the nature of pain. The study assessed the nature and quality of acute postoperative pain using the McGill Pain Questionnaire (MPQ) at specified time points. Although all of the patients' pain was acute postoperative pain, the pain qualities were recorded simultaneously, taking into account the differences in pain qualities. The MPQ was used to evaluate and categorize the nature of pain. The MPQ includes descriptors of pain which are categorized into sensory, affective, evaluative, and miscellaneous dimensions. Each descriptor is rated on an intensity scale of 0 (none) to 3 (severe), and scores are summed to provide an overall pain score. Higher scores indicate worse pain.

  7. Comorbidity Assessment in Relation to Pain and Tryptophan Metabolites

    Time frame: Preoperative anamnesis process: Prior to surgery, during patient assessment, Follow-up: Through study completion, an average of 1 year

    The study recorded patients' comorbidities, specifically those identified during the preoperative anamnesis process, and evaluated their potential impact on the nature of pain and tryptophan metabolites. Comorbidities identified as exclusion criteria, particularly those believed to affect intestinal microbiota and related to abdominal conditions, were also considered. Patients' comorbidities identified during the preoperative anamnesis process were meticulously documented to assess their influence on pain characteristics and tryptophan metabolites. Additionally, comorbidities identified as exclusion criteria due to their potential to alter intestinal microbiota and their association with abdominal conditions were thoroughly evaluated.

  8. Anesthesia induction drugs

    Time frame: During anesthesia procedure

    Although standardization of drugs used in anesthesia is difficult, standardization of induction drugs was partially achieved because the investigators chose a single surgery group. The investigators recorded all of this data during anesthesia applications.

  9. Anesthesia duration and surgery times

    Time frame: During surgery

    Our study detailedly recorded the duration of anesthesia and surgery. To ensure a certain level of standardization, we included only lumbar disc surgery, which is considered sterile. Additionally, surgeries shorter than a specified duration were excluded as they might not provide significant metabolic changes. These durations were carefully recorded throughout the entire surgery and anesthesia period. The investigators accepted these durations as one of the elimination criteria due to their potential impact on pain and physiological mechanisms.

  10. Age of Investigator

    Time frame: Preoperative: During the preoperative anamnesis process

    The investigator's age was recorded during the preoperative anamnesis process to understand its influence on the study variables.

  11. Weight of Investigator

    Time frame: Preoperative: During the preoperative anamnesis process

    The weight of the investigator was recorded during the preoperative anesthesia process to understand its influence on the study variables.

  12. Height of Investigator

    Time frame: Preoperative: During the preoperative anamnesis process

    The height of the investigator was recorded during the preoperative anamnesis process to understand its influence on the study variables.

  13. Body Mass Index (BMI) of Investigator

    Time frame: Preoperative: During the preoperative anamnesis process

    The Body Mass Index (BMI) of the investigator was calculated from recorded height (in meters) and weight (in kilograms) during the preoperative anamnesis process to understand its influence on the study variables.BMI values are reported in units of kg/m².

  14. Gender of Investigator

    Time frame: Preoperative: During the preoperative anamnesis process

    The gender of the investigator was recorded during the preoperative anamnesis process to understand its influence on the study variables.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

The Impact of Microbiota and Associated Blood Tryptophan Metabolites on Pain Perception in Patients Undergoing Lumbar Disc Herniation Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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