Clinical trial

Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07073846

Recruiting nowPhase 4Interventional

What this study is about

The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity. The main questions it aims to answer are: * Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)? * Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo? Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best. Participants will: * Receive an intravenous infusion of their assigned study drug(s) during surgery. * Provide three small blood samples (before surgery, immediately after, and three hours after). * Complete a short pain questionnaire (IPOQ) 24 hours after surgery.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionMorbid Obesity Requiring Bariatric Surgery, Postoperative Pain, Postoperative Pain Management, Postoperative Analgesia, Postoperative Adjuvant Treatment, Postoperative Inflammatory Markers, Postoperative Inflammatory Response

Full registry criteria

Inclusion Criteria: * Adults aged 18 - 60 years * Male or female * Elective laparoscopic bariatric surgery * Post-operative pathway: post-anaesthesia care unit (PACU) followed by standard ward, with an expected in-hospital stay ≥ 24 h * ASA physical-status II or III Exclusion Criteria: * Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural, erector spinae, or other abdominal wall blocks). * Current substance abuse or illicit drug use. * Previous abdominal surgery within the last 6 months. * Known hypersensitivity or allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or α₂-adrenergic agonists. * Congestive heart failure, significant bradyarrhythmia, second- or third-degree atrio-ventricular block without pacemaker, severe hypotension, or current therapy with Class I/III anti-arrhythmic drugs. * Estimated glomerular filtration rate (eGFR) \< 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment). * Severe hepatic impairment (Child-Pugh C). * Pregnancy or lactation. * Chronic opioid consumption \> 30 mg oral morphine equivalents per day for \> 4 weeks * Active seizure disorder, myasthenia gravis, or other neurologic disease contraindicating lidocaine infusion. * Patient cannot communicate * Patient does not want to fill in the questionnaire * Participation in another interventional study within the past 30 days. * Intra-operative conversion to open surgery. * Insufficient biological sample for biomarker analysis. * Premature discontinuation of the study drug during surgery for any reason that, in the judgement of the treating anaesthesiologist or investigators, prevents adequate exposure or assessment of safety variables (e.g., major haemorrhage \> 200 mL, anaphylactic shock, failed intubation, inability to extubate, severe metabolic/respiratory acidosis, transfer to ICU while intubated).

Treatments and study arms

Intravenous Lidocaine infusion + Standard Anesthesia

Drug

Continuous IV infusion of lidocaine 1 % (10 mg mL-¹) at 0.3 mL kg-¹ h-¹ (≈ 1.5 mg kg-¹ h-¹) from induction of anaesthesia to skin closure. No loading bolus, no post-operative infusion.

Intravenous Dexmedetomidine infusion + Standard Anesthesia

Drug

Continuous IV infusion of dexmedetomidine 1 µg mL-¹ at 0.3 mL kg-¹ h-¹ (≈ 0.3 µg kg-¹ h-¹) without loading dose, started after induction and stopped at skin closure. No post-operative infusion.

Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia

Drug

Single syringe containing lidocaine 1 % (10 mg mL-¹) + dexmedetomidine 1 µg mL-¹, infused IV at 0.3 mL kg-¹ h-¹ (delivering ≈ 1.5 mg kg-¹ h-¹ lidocaine + 0.3 µg kg-¹ h-¹ dexmedetomidine) from induction to skin closure.

0.9 % Saline Placebo + Standard Anesthesia

Drug

Volume-matched IV infusion of 0.9 % normal saline at 0.3 mL kg-¹ h-¹ for the same duration and through the same delivery line as active arms; identical syringe appearance.

Primary outcomes

Assessment of postoperative pain patient perception using the Spanish International Pain Outcomes Questionnaire (IPOQ). This questionnaire includes multiple items assessed on a numerical rating scale (NRS) from 0 to 10.24 hours post-operative

* For most items (e.g., pain intensity, interference with activities, emotional impact), \*\*higher scores indicate worse outcomes\*\*. * For items such as pain relief and satisfaction, \*\*higher scores indicate better outcomes\*\*. Items include: * Highest and lowest pain intensity experienced since surgery * Proportion of time spent in pain * How pain limited physical activities (e.g., coughing, moving, walking) * Impact of pain on mood and emotional well-being * Adverse effects attributed to pain medication (e.g., nausea, dizziness) * Overall degree of pain relief obtained * Desire for additional analgesic treatment * Clarity and usefulness of information received about pain therapy * Extent of patient involvement in treatment decisions * Global satisfaction with pain management * Use of non-pharmacological methods for pain relief * Presence of pre-existing pain before hospital admi…

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Hospital de Especialidades Centro Medico Nacional Siglo XXI🇲🇽 Mexico City, Mexico City, Mexico
Dulce María Rascón Martínez, MScContact
Arnulfo Calixto Flores, ResearcherContact
Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI🇲🇽 Mexico City, Mexico City, Mexico
Dulce M Rascón Martínez, MD, MScContact
Arnulfo Calixto Flores, MD, PhDContact
Lourdes A Arriaga Pizano, MD, PhDSub Investigator