Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy

Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy a Randomized Double-blind Clinical Trial

Opioid sparing analgesia: Continuous intraoperative infusion of dexmedetomidine versus lidocaine for laparoscopic cholecystectomy, a randomized double-blind clinical trial.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Dexmedetomidine Injection [Precedex]; Drug: Lidocaine IV

Detailed Description

Postoperative pain represents one of the most common complaints following surgeries. Despite advances in modern medicine, pain following surgical procedures is still a challenge for anesthetists, though significant progress made over the past decades. The mechanism of pain following laparoscopic procedures is thought to be multifactorial. The main causes of pain after laparoscopic cholecystectomy (LC) are pain from the incision site, pneumoperitoneum and cholecystectomy. Clinicians using different methods for analgesia after LC. like non-steroidal anti-inflammatory drugs, intraperitoneal local anesthetics, local anesthetics applied to the wound site, removal of the insufflation gas, paravertebral block (PVB), and epidural block. To date, the mainstay of management has been the administration of exogenous opioids such as morphine or fentanyl. However, pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. In addition to that, many patients and even some clinicians wrongly believe that addiction can be inevitable after administration of opioids. Dexmedetomidine is an alpha 2-adrenergic agonist which is a relatively new drug used for procedural sedation. It has sedative and anxiolytic effects and is known for its analgesic potential owing to a reduction of sympathetic tone. Dexmedetomidine has dose-dependent effects, ranging from minimal to deep sedation. Moreover, except at doses that cause very deep sedation or general anesthesia, the sedation is reversible. These are unique properties among the sedative medications in common use. Dexmedetomidine does not impair the respiratory drive per se and seldom causes apnea. However, it has been shown to impair the respiratory responses to hypoxia and hypercapnia and can cause hemodynamic effects such as hypertension, hypotension and bradycardia. Systemic lidocaine has centrally and peripherally analgesic, anti-hyperalgesic and anti-inflammatory effects with reduced side-effects especially if used with appropriate dose. Recently, intravenous lidocaine infusion is considered a part of analgesic therapy regimen that decreases postoperative opioid requirements and enhances convalescence after major surgeries. Dexmedetomidine and lidocaine are common adjuvant medicine anesthetics during operation for the sedative and analgesic properties. Besides, some studies have proved that both are effective in relieving postoperative pain in adults. However, there are very limited studies comparing the effects of the two adjuvant analgesics on postoperative pain in patients undergoing laparoscopic cholecystectomy (LC).

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt
      • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient's status ASA status-I and II.
• Patients age above 18 years old.
• Patients scheduled for laparoscopic cholecystectomy.

Exclusion Criteria:

• Patient refusal.
• Patients with known allergy to dexmedetomidine or lidocaine.
• Patients with significant hepatic dysfunction.
• Patients with severe renal disease.
• Patients with chronic pain.
• Regular use analgesics, antidepressants or opioids in last month.
• Any known convulsive disorder.
• Significant heart disease.
• Morbid obesity (BMI>35).
• Patients with autoimmune disease
• Patients on corticosteroid therapy
• Pregnancy
• Breast feeding
• Woman under hormonal treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; This group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].	Drug: Dexmedetomidine Injection [Precedex]; dexmedetomidine group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].The continuous intraoperative IV infusion of study drug will be stopped 10 min before the end the surgical procedure.
Experimental: Lidocaine group; This group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance].	Drug: Lidocaine IV; lidocaine group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance]. The continuous intraoperative IV infusion of study drug will be stopped 10 min before the end the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Numeric Pain Rating Scale	Numeric Pain Rating Scale (NPRS) will be explained to the patient to be able to choose the score that best expressed the intensity of pain postoperatively ranging from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richmond Agitation-Sedation Scale	Richmond Agitation-Sedation Scale (RASS) will be used to evaluate the level of sedation in post-anesthesia care unit (PACU), It is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation, ranging from +4 to -5, desirable score is 0 to -2.	15 minutes
First call for rescue analgesic (Nalbuphine)		1 day
The total postoperative Nalbuphine consumption		1 day
Intraoperative automated non-invasive blood pressure monitoring.		1 hour
Intraoperative electrocardiogram (ECG) heart rate monitoring.		1 hour
The mean duration of PACU stay.		3 hours

Other Outcome Measures

Outcome Measure	Time Frame
Side effects of study drugs.	1 hour
Satisfaction of the patients questionnaire	1 day

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohamed S. Saad, Dr, Assiut University Hospitals

Publications and helpful links

General Publications

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
• Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
• Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.
• Mitra S, Carlyle D, Kodumudi G, Kodumudi V, Vadivelu N. New Advances in Acute Postoperative Pain Management. Curr Pain Headache Rep. 2018 Apr 4;22(5):35. doi: 10.1007/s11916-018-0690-8.
• Meera A. Pain and Opioid Dependence: Is it a Matter of Concern. Indian J Palliat Care. 2011 Jan;17(Suppl):S36-8. doi: 10.4103/0973-1075.76240.
• Barends CR, Absalom A, van Minnen B, Vissink A, Visser A. Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety. PLoS One. 2017 Jan 20;12(1):e0169525. doi: 10.1371/journal.pone.0169525. eCollection 2017.
• Batko I, Koscielniak-Merak B, Tomasik PJ, Kobylarz K, Wordliczek J. Lidocaine as an element of multimodal analgesic therapy in major spine surgical procedures in children: a prospective, randomized, double-blind study. Pharmacol Rep. 2020 Jun;72(3):744-755. doi: 10.1007/s43440-020-00100-7. Epub 2020 Apr 15.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: Analgesia in cholecystectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No