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Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult

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ClinicalTrials.gov Identifier: NCT03481517
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
Acute appendicitis is one of the most common acute abdomens that need surgical intervention. Laparoscopic surgery much decreases postoperative pain of wound, however, pain remains an important determinant of recovery after surgery. Intraoperative local anesthetic agent infiltrated locally into surgical wound to relieve postoperative pain is a feasible and safe method suggested in some literature. However, there is no routine use of this method in clinical practice because its benefit is still unknown. Besides, very few evidence could be found in literature review. To date, there is still no double blinded, prospective, randomized control trial addressing in evaluation of its interest. In this study, the investigators aim at investigating the benefit of wound infiltration with local anesthetic agent (bupivacaine) for laparoscopic appendectomy in adult. The study design is a double blind, prospective, randomized control trial with a 1:1 allocation ratio. Fifty adult patients with appendicitis will be included. The control group undergo laparoscopic appendectomy without wound infiltration with local anesthetic agent, the intervention group undergo laparoscopic appendectomy with wound infiltration with local anesthetic agent intraoperatively. The clinical characteristics, outcomes, and patient's satisfaction will be recorded and analyzed. The investigators hope this study can provide a high level evidence in pain management of patient undergo laparoscopic surgery.

Condition or disease Intervention/treatment Phase
Appendicitis Acute Drug: Bupivacaine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Interest of Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult: a Double Blind, Prospective, Randomized Control Trial
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Wound with local anesthesia
5 mL Bupivacaine is injected into subcutaneous area near surgical wound
 Drug: Bupivacaine
Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.
Other Name: Marcaine
No Intervention: Wound without local anesthesia
Nothing is injected into subcutaneous area near surgical wound


Outcome Measures
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Primary Outcome Measures :
  1. Pain score of surgical wound of the patient [ Time Frame: within 24 hours after surgery ]
    Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient


Secondary Outcome Measures :
  1. Satisfaction of the patient [ Time Frame: up to one month after surgery ]
    Using questionnaire to evaluate satisfaction of the patient about surgery and hospitalization.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Including criteria:

  1. Clinical diagnosis of appendicitis and undergo laparoscopic appendectomy
  2. Age more than 20 years
  3. Well comprehensive in speaking Chinese

Exclusion criteria:

  1. Age no more than 20 years
  2. Pregnancy
  3. Can not cooperate with evaluation
  4. Convert to open surgical method, resect more organs than appendix
  5. Using patient control analgesia
  6. Allergy to local anesthetic agent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481517


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chih-Yang Hsiao, M.D. National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03481517    
Other Study ID Numbers: 201710064RINB
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
adult
appendectomy
appendicitis
local anesthesia
pain
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
 Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents