Clinical trial NCT06502223: Impact of Gut Microbiota and Tryptophan Metabolites on Acute Pain in Lumbar Disc Herniation Surgery Patients
Official title: The Impact of Microbiota and Associated Blood Tryptophan Metabolites on Pain Perception in Patients Undergoing Lumbar Disc Herniation Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Substitution
Tryptophan Metabolism Alterations
Postoperative Pain, Acute
Keywords: Microbiota
Tryptophan
Picolinic Acid
Kynurenic Acid
Xanthurenic Acid
Quinolinic Acid
Acute Pain
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our study includes 37 lumbar disc herniation (LDH) surgeries performed in Dokuz Eylül University Faculty of Medicine Central Operating Rooms Brain and Nerve Surgery Hall. For the blood samples in which the investigators evaluated tryptophan metabolites; 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.

Concurrently with each blood draw, the patient's VAS score, the nature of the pain, and vital signs were recorded. Patient records, clinical histories, examination findings, and relevant laboratory results were electronically recorded.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Tryptophan metabolites (Picolinic Acid)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Tryptophan metabolites (3-Hydroxykynurenine)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Tryptophan metabolites (Anthranilic Acid)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Tryptophan metabolites (Kynurenine)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Tryptophan metabolites (Quinolinic Acid)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Tryptophan metabolites (Kynurenic Acid)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Tryptophan metabolites (Xanthurenic Acid)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Visual Analog Scale
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
Secondary outcomes:
measure: Systolic Blood Pressure (mmHg)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Diastolic Blood Pressure (mmHg)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Pulse Rate (beats per minute)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Respiratory Rate (breaths per minute)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Oxygen Saturation (%)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Nature of Postoperative Pain Assessed by the McGill Pain Questionnaire (MPQ)
timeFrame: Preoperative: Before surgery; Postoperative 8th-hour: 8 hours after surgery;Postoperative 24th-hour: 24 hours after surgery
measure: Comorbidity Assessment in Relation to Pain and Tryptophan Metabolites
timeFrame: Preoperative anamnesis process: Prior to surgery, during patient assessment, Follow-up: Through study completion, an average of 1 year
measure: Anesthesia induction drugs
timeFrame: During anesthesia procedure
measure: Anesthesia duration and surgery times
timeFrame: During surgery
measure: Age of Investigator
timeFrame: Preoperative: During the preoperative anamnesis process
measure: Weight of Investigator
timeFrame: Preoperative: During the preoperative anamnesis process
measure: Height of Investigator
timeFrame: Preoperative: During the preoperative anamnesis process
measure: Body Mass Index (BMI) of Investigator
timeFrame: Preoperative: During the preoperative anamnesis process
measure: Gender of Investigator
timeFrame: Preoperative: During the preoperative anamnesis process
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Yunu Çelik
state: Balçova
Study officials:
affiliation: Dokuz Eylül University Hospital, Faculty of Medicine
name: Yunus Celik, M.D.
role: STUDY_CHAIR
References: