Gall Bladder Bed Infiltration Analgesia

Pain, Acute Clinical Trial

Official title:

The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693820
• Other study ID #: MS.18.09.277
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: July 11, 2019

Study information

• Verified date: October 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 11, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
Egypt	Gastro-enterolgy surgical center, Mansoura University	Mansourah	Al-Dakahleia

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Mazy Mazy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total postoperative analgesic consumption	ketorolac and morphine in mg .	postoperative, for 24 hours
Secondary	The time to the first request of analgesia	hours	postoperative, for 24 hours
Secondary	The intraoperative fentanyl requirements.	microgram	intraoperative
Secondary	postoperative pain score: VAS	visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,	postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
Secondary	heart rate	beat/ minute	basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
Secondary	mean blood pressure	mmHg	basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
Secondary	incidence of vomiting	number	postoperatively, during the first 24 hours
Secondary	the sleep quality	through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.	postoperatively, after the first night.
Secondary	Patient satisfaction regards analgesia:	using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.	postoperative after 24 hour.
Secondary	Surgeon satisfaction regards the technique:	using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.	postoperative within 1 hour.