Postoperative analgesic effect of intravenous coinjection of lidocaine and dexmedetomidine in gynaecological surgery: a systematic review and meta-analysis.
Dan Xie, Fangjun Wang, Wen Wen...
https://pubmed.ncbi.nlm.nih.gov/39663167Actively Recruiting
Phase 4
Age: 18Years - 60Years
All Genders
ID07073846
Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery
Led by Instituto Mexicano del Seguro Social · Updated on 2025-11-28
104
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving a combination of intravenous lidocaine and dexmedetomidine (LIDEX) during laparoscopic bariatric surgery can reduce post-operative pain, inflammation, and oxidative stress in adults with obesity. This randomized clinical trial compares four groups: lidocaine alone, dexmedetomidine alone, the combination LIDEX, and a saline placebo. The study aims to understand which approach best controls pain and lowers inflammatory and oxidative markers after surgery. Participants receive an intravenous infusion of their assigned study drug(s) during surgery, from the induction of anesthesia until skin closure. Four groups are studied: lidocaine infusion, dexmedetomidine infusion, the LIDEX combination in one syringe, and a saline placebo infusion. No post-operative infusions are given. Blood samples are collected before surgery, immediately after, and three hours postoperatively to measure inflammatory cytokines and oxidative stress markers. During the study, pain is evaluated 24 hours after surgery using the International Pain Outcomes Questionnaire (IPOQ). Researchers continuously monitor heart rate and blood pressure for safety, with predefined rescue steps if needed. Participants are expected to stay in the hospital for at least 24 hours post-surgery. The study will assess patient-reported pain, blood biomarkers, and safety measures to determine the effects of the treatments.
CONDITIONS
Brief Title
Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 - 60 years
- Male or female
- Scheduled for elective laparoscopic bariatric surgery
- Post-operative care includes PACU and standard ward with expected hospital stay of at least 24 hours
- ASA physical status II or III
You will not qualify if you...
- Use of any loco-regional anaesthetic techniques during peri-operative period
- Current substance abuse or illicit drug use
- Previous abdominal surgery within last 6 months
- Known allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or alpha-2 adrenergic agonists
- Congestive heart failure, significant bradyarrhythmia, certain heart blocks without pacemaker, severe hypotension, or use of Class I/III anti-arrhythmic drugs
- Moderate to severe kidney impairment (eGFR < 60 mL/min/1.73 m2)
- Severe liver impairment (Child-Pugh C)
- Pregnancy or breastfeeding
- Chronic opioid use over 30 mg morphine equivalents daily for more than 4 weeks
- Active seizure disorder, myasthenia gravis, or neurological diseases contraindicating lidocaine
- Inability to communicate or refusal to complete questionnaires
- Participation in another interventional study within past 30 days
- Intra-operative conversion to open surgery
- Insufficient biological sample for biomarker analysis
- Early stopping of study drug during surgery due to safety concerns or complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of surgery (intra-operative period)
Participants undergo laparoscopic bariatric surgery and receive an intra-operative intravenous infusion of lidocaine, dexmedetomidine, their combination, or placebo during surgery from induction of anesthesia to skin closure.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 24 hours post-operative
Participants have post-operative monitoring of pain using a questionnaire and blood sampling to assess inflammatory and oxidative stress markers up to a few hours after surgery.
Approximately 1 to 2 visits within 24 hours after surgery
Trial Site Locations
Total: 2 locations
1
Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, Mexico City, Mexico, 06720
Actively Recruiting
2
Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI
Mexico City, Mexico City, Mexico, 06720
Actively Recruiting
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Research Team
D
Dulce M Rascón Martínez, Prof MD, MSc
A
Arnulfo Calixto Flores, Prof MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study.
Martina Rekatsina, Polyxeni Theodosopoulou, Chryssoula Staikou
https://pubmed.ncbi.nlm.nih.gov/34704710Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials.
Yu Zhang, Ying Zhou, Tao Hu...
https://pubmed.ncbi.nlm.nih.gov/35422388Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty.
Caio Marcio Barros de Oliveira, Lais Maria Gaspar Coelho, José Aparecido Valadão...
https://pubmed.ncbi.nlm.nih.gov/32533519Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-α in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial.
Siqi Xu, Shenghong Hu, Xia Ju...
https://pubmed.ncbi.nlm.nih.gov/33407156Comparison of the Effects of Dexmedetomidine and Lidocaine on Stress Response and Postoperative Delirium of Older Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial.
Yuan Lai, Qi Chen, Chunfang Xiang...
https://pubmed.ncbi.nlm.nih.gov/37554513Dexmedetomidine Attenuates Inflammation in Elderly Patients Following Major Hepatobiliary and Pancreatic Surgery: A Randomized Clinical Trial.
Xingtong Chen, Qian Chen, Zhigang Qin...
https://pubmed.ncbi.nlm.nih.gov/38827237Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial.
Yoshinori Ohta, Kyohei Miyamoto, Yu Kawazoe...
https://pubmed.ncbi.nlm.nih.gov/32778146The effect of dexmedetomidine on inflammatory response of septic rats.
Jianxing Zhang, Zhipeng Wang, Yan Wang...
https://pubmed.ncbi.nlm.nih.gov/25929655Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial.
Dong-Jian Ge, Bin Qi, Gang Tang...
https://pubmed.ncbi.nlm.nih.gov/26903197