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Gall Bladder Bed Infiltration Analgesia

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ClinicalTrials.gov Identifier: NCT03693820
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Alaa Mazy, Mansoura University

Brief Summary:
Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: the infiltration group Drug: the control group Not Applicable

Detailed Description:

Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg position will be maintained for 2 minutes.

In the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: the infiltration cocktail of local anesthetic will be replaced by saline in the same volume.
Primary Purpose: Prevention
Official Title: The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: the infiltration group
a cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space and another 50-75ml over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China).
Drug: the infiltration group
  • 15-20 ml periportal,
  • 50 ml in gallbladder bed,
  • The rest (about 150 ml in 70 Kg patient) will be intraperitoneal

Placebo Comparator: the control group
the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.
Drug: the control group
the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.




Primary Outcome Measures :
  1. The total postoperative analgesic consumption [ Time Frame: postoperative, for 24 hours ]
    ketorolac and morphine in mg .


Secondary Outcome Measures :
  1. The time to the first request of analgesia [ Time Frame: postoperative, for 24 hours ]
    hours

  2. The intraoperative fentanyl requirements. [ Time Frame: intraoperative ]
    microgram

  3. postoperative pain score: VAS [ Time Frame: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours ]
    visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,

  4. heart rate [ Time Frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively. ]
    beat/ minute

  5. mean blood pressure [ Time Frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively. ]
    mmHg

  6. incidence of vomiting [ Time Frame: postoperatively, during the first 24 hours ]
    number

  7. the sleep quality [ Time Frame: postoperatively, after the first night. ]
    through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.

  8. Patient satisfaction regards analgesia: [ Time Frame: postoperative after 24 hour. ]
    using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.

  9. Surgeon satisfaction regards the technique: [ Time Frame: postoperative within 1 hour. ]
    using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo elective laparoscopic cholecystectomy.
  • American Society of Anesthesiologists physical status (ASA) I or II.

Exclusion Criteria:

  1. Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
  2. Patient with spillage or cholelithiasis with known common bile duct pathology.
  3. Body Mass Index > 40 Kg/m2.
  4. Patient underlying severe systemic disease.
  5. Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.

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): NCT03693820


Contacts
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Contact: alaa alaa.mazy, MD 01140065052 alaa_mazy@yahoo.com
Contact: Ahmed Sadek, MBBCH 00201003130299 dr.storm88@gmail.com

Locations
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Egypt
Gastro-enterolgy surgical center, Mansoura University Recruiting
Mansourah, Al-Dakahleia, Egypt, 35516
Contact: ahmad M Sadek, MBBCH    +201003130299    dr.storm88@gmail.com   
Principal Investigator: Ahmed M Mahmoud Sadik Mohammed, MBBCH         
Sub-Investigator: Monir Othman, MD         
Sub-Investigator: Alaa Mazy Abdou Mazy, MD         
Sub-Investigator: Ibrahim Abd Elbasir, MD         
Sponsors and Collaborators
Alaa Mazy
Investigators
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Study Director: alaa mazy, MD faculty of medicine, Mansoura

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Responsible Party: Alaa Mazy, associate prosseor, Mansoura University
ClinicalTrials.gov Identifier: NCT03693820     History of Changes
Other Study ID Numbers: MS.18.09.277
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

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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 Alaa Mazy, Mansoura University:
cholecystectomy;
analgesia;
gallbladder;
infiltration;
visceral pain

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms