Lidocaine and Analgesia After Laparoscopic Cholecystectomy

• Sponsor: Larissa University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03620591
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Opioid Consumption	Drug: Lidocaine; Drug: Placebo	N/A

Detailed Description

Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.

Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
• Actual Study Start Date: Jul 2, 2018
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lidocaine Intraoperative administration of lidocaine to patients undergo laparoscopic cholecystectomy. Prior induction to anesthesia, lidocaine bolus 1.5 mg / kg will be administered to the lidocaine group and then patients will be connected to a continuous 2 mg / kg / h administration of lidocaine until the end of the procedure.	Drug: Lidocaine; Intraoperative administration of lidocaine
Placebo Comparator: Placebo Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.	Drug: Placebo; Intraoperative administration of normal saline

Outcome Measures

Primary Outcome Measures

1. Postoperative opioid consumption [24 hours after the procedure]

   The total dose of tramadol is calculated as mg and administered intravenously.

Secondary Outcome Measures

1. Postoperative pain [Departure of the patient from the recovery room (0hrs)]

   Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

2. Postoperative pain [6 hrs after the procedure]

   Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

3. Postoperative pain [12 hrs after the procedure]

   Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

4. Postoperative pain [24 hrs after the procedure]

   Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

5. Incidence of Nausea and Vomiting [24 hours]

   The percentage of patients who had nausea and vomiting during the first 24 hours

6. Incidence of sedation and respiratory depression [24 hours]

   The percentage of patients who had sedation and respiratory depression during the first 24 hours

7. Incidence of shoulder pain [24 hours]

   The percentage of patients who had shoulder pain during the first24 hours

8. Incidence of headache and dizziness [24 hours]

   The percentage of patients who had headache and dizziness during the first 24 hours

9. Change from baseline Mean Blood Pressure [Intraoperative]

   Non-invasive blood pressure measurement by using sphygmomanometer cuff

10. Change from Baseline Heart Rate [Intraoperative]

    Bradycardia, tachycardia during the procedure

11. Change in depth of anesthesia [Intraoperative]

    Maintenance of Bispectral index (BIS) values of 40 to 50

12. Side effect related to administration of lidocaine [24 hours]

    The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA physical status I-II

• Age ≥ 18 years old

• BMI ≤ 35

Exclusion Criteria:

• Allergy in local anesthetics

• History of liver, kidney or heart failure

• Existence of chronic pain history or daily analgesics

• Psychiatric disorders

• Inability to understand pain assessment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Larissa	Larissa		Greece	41110

Sponsors and Collaborators

• Larissa University Hospital

Investigators

• Study Director: Ioannis Baloyiannis, University Hospital of Larissa
• Principal Investigator: Chamaidi Sarakatsianou, University Hospital of Larissa
• Study Chair: Stavroula Georgopoulou, University Hospital of Larissa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ioannis Baloyiannis, Assistant Professor of Surgery, Larissa University Hospital
• ClinicalTrials.gov Identifier: NCT03620591
• Other Study ID Numbers: UHL27823/06/28/2018
• First Posted: Aug 8, 2018
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ioannis Baloyiannis, Assistant Professor of Surgery, Larissa University Hospital: Lidocaine; Postoperative Pain; Opioid consumption; Laparoscopic cholecystectomy
• Additional relevant MeSH terms: Pain, Postoperative; Lidocaine

Study Results

No Results Posted as of Apr 5, 2022