Gall Bladder Bed Infiltration Analgesia

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Drug: the control group; Drug: the infiltration group

• Registration Number: NCT03693820
• Lead Sponsor: Alaa Mazy Mazy

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 Timeline

• Study Start: 2018-09-10
• Status Verified: 2018-10
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-11
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	the control group	the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.
the infiltration group	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).

Primary Outcome Measures

Name	Time	Method
The total postoperative analgesic consumption	postoperative, for 24 hours	ketorolac and morphine in mg .

Secondary Outcome Measures

Name	Time	Method
The intraoperative fentanyl requirements.	intraoperative	microgram
postoperative pain score: VAS	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	basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.	beat/ minute
mean blood pressure	basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.	mmHg
incidence of vomiting	postoperatively, during the first 24 hours	number
The time to the first request of analgesia	postoperative, for 24 hours	hours
Patient satisfaction regards analgesia:	postoperative after 24 hour.	using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
the sleep quality	postoperatively, after the first night.	through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.
Surgeon satisfaction regards the technique:	postoperative within 1 hour.	using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.

Trial Locations

Locations (1)

Gastro-enterolgy surgical center, Mansoura University; 🇪🇬 Mansourah, Al-Dakahleia, Egypt