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
|Condition or disease||Intervention/treatment||Phase|
|Pain, Acute||Drug: the infiltration group Drug: the control group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|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.|
|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|
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
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.
- The total postoperative analgesic consumption [ Time Frame: postoperative, for 24 hours ]ketorolac and morphine in mg .
- The time to the first request of analgesia [ Time Frame: postoperative, for 24 hours ]hours
- The intraoperative fentanyl requirements. [ Time Frame: intraoperative ]microgram
- 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,
- 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
- 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
- incidence of vomiting [ Time Frame: postoperatively, during the first 24 hours ]number
- 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.
- Patient satisfaction regards analgesia: [ Time Frame: postoperative after 24 hour. ]using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
- Surgeon satisfaction regards the technique: [ Time Frame: postoperative within 1 hour. ]using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.
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
|Contact: alaa alaa.mazy, MDemail@example.com|
|Contact: Ahmed Sadek, MBBCHfirstname.lastname@example.org|
|Gastro-enterolgy surgical center, Mansoura University||Recruiting|
|Mansourah, Al-Dakahleia, Egypt, 35516|
|Contact: ahmad M Sadek, MBBCH +201003130299 email@example.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|
|Study Director:||alaa mazy, MD||faculty of medicine, Mansoura|