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Gall Bladder Bed Infiltration Analgesia

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
the infiltration group
the control group
Sponsored by
Alaa Mazy Mazy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute focused on measuring cholecystectomy;, analgesia;, gallbladder;, infiltration;, visceral pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gastro-enterolgy surgical center, Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

the infiltration group

the control group

Arm Description

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).

the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.

Outcomes

Primary Outcome Measures

The total postoperative analgesic consumption
ketorolac and morphine in mg .

Secondary Outcome Measures

The time to the first request of analgesia
hours
The intraoperative fentanyl requirements.
microgram
postoperative pain score: VAS
visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,
heart rate
beat/ minute
mean blood pressure
mmHg
incidence of vomiting
number
the sleep quality
through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.
Patient satisfaction regards analgesia:
using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
Surgeon satisfaction regards the technique:
using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.

Full Information

First Posted
October 1, 2018
Last Updated
September 16, 2020
Sponsor
Alaa Mazy Mazy
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1. Study Identification

Unique Protocol Identification Number
NCT03693820
Brief Title
Gall Bladder Bed Infiltration Analgesia
Official Title
The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Mazy Mazy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
cholecystectomy;, analgesia;, gallbladder;, infiltration;, visceral pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
the infiltration cocktail of local anesthetic will be replaced by saline in the same volume.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the infiltration group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.
Intervention Type
Drug
Intervention Name(s)
the infiltration group
Intervention Description
15-20 ml periportal, 50 ml in gallbladder bed, The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
Intervention Type
Drug
Intervention Name(s)
the control group
Intervention Description
the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.
Primary Outcome Measure Information:
Title
The total postoperative analgesic consumption
Description
ketorolac and morphine in mg .
Time Frame
postoperative, for 24 hours
Secondary Outcome Measure Information:
Title
The time to the first request of analgesia
Description
hours
Time Frame
postoperative, for 24 hours
Title
The intraoperative fentanyl requirements.
Description
microgram
Time Frame
intraoperative
Title
postoperative pain score: VAS
Description
visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,
Time Frame
postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
Title
heart rate
Description
beat/ minute
Time Frame
basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
Title
mean blood pressure
Description
mmHg
Time Frame
basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
Title
incidence of vomiting
Description
number
Time Frame
postoperatively, during the first 24 hours
Title
the sleep quality
Description
through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.
Time Frame
postoperatively, after the first night.
Title
Patient satisfaction regards analgesia:
Description
using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
Time Frame
postoperative after 24 hour.
Title
Surgeon satisfaction regards the technique:
Description
using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.
Time Frame
postoperative within 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo elective laparoscopic cholecystectomy. American Society of Anesthesiologists physical status (ASA) I or II. Exclusion Criteria: Patient in receipt of analgesics or sedatives 24 h before scheduled surgery. Patient with spillage or cholelithiasis with known common bile duct pathology. Body Mass Index > 40 Kg/m2. Patient underlying severe systemic disease. Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alaa mazy, MD
Organizational Affiliation
faculty of medicine, Mansoura
Official's Role
Study Director
Facility Information:
Facility Name
Gastro-enterolgy surgical center, Mansoura University
City
Mansourah
State/Province
Al-Dakahleia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

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Gall Bladder Bed Infiltration Analgesia

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