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

Instituto Mexicano del Seguro Social

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain; Postoperative Analgesia; Postoperative Pain Management; Morbid Obesity Requiring Bariatric Surgery; Postoperative Inflammatory Markers; Postoperative Adjuvant Treatment; Postoperative Inflammatory Response

Treatments: Drug: 0.9 % Saline Placebo + Standard Anesthesia; Drug: Intravenous Lidocaine infusion + Standard Anesthesia; Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia; Drug: Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07073846

R-2025-3601-197

Details and patient eligibility

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.

Full description

Obesity is associated with chronic low-grade inflammation and persistent oxidative stress. Laparoscopic bariatric surgery-although highly effective for weight reduction-triggers an acute inflammatory cascade and a burst of reactive oxygen species that can amplify post-operative pain and delay functional recovery.

Intravenous lidocaine stabilises voltage-gated Na+ channels, limits ectopic neuronal firing and inhibits neutrophil priming; it also down-regulates the release of pro-inflammatory cytokines in abdominal procedures. Dexmedetomidine, a highly selective α2-adrenergic agonist, produces sedation and analgesia while attenuating sympathetic outflow, thereby reducing surgical catecholamine surges and cytokine release. Pre-clinical and clinical synergy studies indicate that combining these two agents (LIDEX) can provide additive anti-hyperalgesic, anti-inflammatory and antioxidant effects without increasing cardiovascular risk when each is dosed within its established therapeutic window.

In this protocol, a weight-adjusted intra-operative infusion of lidocaine plus dexmedetomidine is administered during bariatric surgery and compared with each single agent and saline. Peri-operative venous samples are collected for mechanistic profiling of systemic inflammatory and redox responses, and patient-reported pain is captured after surgery using a validated instrument. Haemodynamic parameters are continuously monitored to detect potential lidocaine toxicity or dexmedetomidine-related bradycardia and hypotension; predefined rescue algorithms are applied if thresholds are exceeded.

The study is designed to clarify whether the LIDEX combination can blunt the acute inflammatory-oxidative surge thought to drive sustained pain and metabolic stress after bariatric surgery, thereby informing future enhanced-recovery protocols that integrate multimodal analgesia with metabolic optimisation strategies.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

Lidocaine Infusion (LID)

Active Comparator group

Description:

Intra-operative IV lidocaine 1 % at ≈ 1.5 mg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹). Infusion starts after induction and stops at skin closure; no post-operative infusion.

Treatment:

Drug: Intravenous Lidocaine infusion + Standard Anesthesia

Dexmedetomidine Infusion (DEX)

Active Comparator group

Description:

Intra-operative IV dexmedetomidine ≈ 0.3 µg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹) without loading dose, from induction to skin closure.

Treatment:

Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia

Lidocaine + Dexmedetomidine (LIDEX)

Experimental group

Description:

Concurrent IV lidocaine 1 % (1.5 mg·kg-¹·h-¹) plus dexmedetomidine (0.3 µg·kg-¹·h-¹) in the same syringe, administered from induction to skin closure.

Treatment:

Drug: Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia

Saline Placebo

Placebo Comparator group

Description:

IV 0.9 % saline at 0.3 mL·kg-¹·h-¹ for the same duration as active arms; syringe identical in appearance.

Treatment:

Drug: 0.9 % Saline Placebo + Standard Anesthesia