Gall Bladder Bed Infiltration Analgesia

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Alaa Mazy，Mansoura University

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

September 10, 2018

Estimated Primary Completion Date

September 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The total postoperative analgesic consumption[ Time Frame: postoperative, for 24 hours ]

ketorolac and morphine in mg .

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Gall Bladder Bed Infiltration Analgesia

Official Title ^ICMJE

The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:the infiltration cocktail of local anesthetic will be replaced by saline in the same volume.
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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
Drug: the control group
the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2019

Estimated Primary Completion Date

September 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Egypt

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

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

Plan to Share IPD:

Responsible Party

Alaa Mazy，Mansoura University

Study Sponsor ^ICMJE

Alaa Mazy

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: alaa mazy, MD faculty of medicine, Mansoura

PRS Account

Mansoura University

Verification Date

October 2018

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

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