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Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT04609033
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Esam Hamed, Assiut University

Tracking Information
First Submitted Date  ICMJE September 3, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE October 24, 2020
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
visual analogue scale [ Time Frame: 24 hours ]
scale to measure pain intensity graded fron 0 = no pain to 10 = worst pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
Official Title  ICMJE Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
Brief Summary Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively
Detailed Description

The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Perioperative Pain
Intervention  ICMJE
  • Drug: Bupivacaine
    instillation of local anaesthetic in the abdominal cavity at the end of the procedure
  • Drug: isotonic saline
    instillation of local anaesthetic in the abdominal cavity at the end of the procedure
  • Drug: Bupivacaine + morphine
    instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
  • Drug: Bupivacaine + morphine + ketamine
    instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure
Study Arms  ICMJE
  • Active Comparator: bupivacaine group
    Intervention: Drug: Bupivacaine
  • Active Comparator: bupivacaine + morphine
    Intervention: Drug: Bupivacaine + morphine
  • Active Comparator: bupivacaine + morphine + ketamine
    Intervention: Drug: Bupivacaine + morphine + ketamine
  • Placebo Comparator: isotonic saline
    Intervention: Drug: isotonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for Laparoscopic cholecystectomy.
  • Age spectrum of 18 - 55 years
  • ASA I, II
  • Have no comorbid chronic medical diseases

Exclusion Criteria:

  • Patients with co morbid medical diseases
  • Age outside the specified range
  • Acute inflammation of the gall bladder
  • Critically ill patient
  • Emergency operations
  • Patient refusal
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04609033
Other Study ID Numbers  ICMJE 17300477
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esam Hamed, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP