Clinical trial NCT03693820: Gall Bladder Bed Infiltration Analgesia
Official title: The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: cholecystectomy;
analgesia;
gallbladder;
infiltration;
visceral pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The total postoperative analgesic consumption
timeFrame: postoperative, for 24 hours
Secondary outcomes:
measure: The time to the first request of analgesia
timeFrame: postoperative, for 24 hours
measure: The intraoperative fentanyl requirements.
timeFrame: intraoperative
measure: postoperative pain score: VAS
timeFrame: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours
measure: heart rate
timeFrame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
measure: mean blood pressure
timeFrame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.
measure: incidence of vomiting
timeFrame: postoperatively, during the first 24 hours
measure: the sleep quality
timeFrame: postoperatively, after the first night.
measure: Patient satisfaction regards analgesia:
timeFrame: postoperative after 24 hour.
measure: Surgeon satisfaction regards the technique:
timeFrame: postoperative within 1 hour.
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Gastro-enterolgy surgical center, Mansoura University
state: Al-Dakahleia
Study officials:
affiliation: faculty of medicine, Mansoura
name: alaa mazy, MD
role: STUDY_DIRECTOR
References: