Gall Bladder Bed Infiltration Analgesia

NCT03693820 — Not applicable, Completed, 70 participants, Alaa Mazy Mazy

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The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

Registry	NCT03693820
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	70 (Actual)
Sponsor	Alaa Mazy Mazy (Other)
Conditions	Pain, Acute
Interventions	the infiltration group, the control group (Drug)
Dates	start 2018-09-10, primary completion 2019-06-01, completion 2019-07-11, first posted 2018-10-03, last updated 2020-09-18
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
the infiltration group	Active comparator	Drug: 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).
the control group	Placebo comparator	Drug: the control group	the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.

the infiltration group (Drug): * 15-20 ml periportal, * 50 ml in gallbladder bed, * The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
the control group (Drug): the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

+Outcome measures

Primary outcomes

The total postoperative analgesic consumption [postoperative, for 24 hours]: ketorolac and morphine in mg .

Secondary outcomes

The time to the first request of analgesia [postoperative, for 24 hours]: hours
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 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.
Patient satisfaction regards analgesia: [postoperative after 24 hour.]: using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
Surgeon satisfaction regards the technique: [postoperative within 1 hour.]: using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.

+Eligibility

Sex: All, ages: 20 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Gastro-enterolgy surgical center, Mansoura University	Al Mansurah, Al-Dakahleia	Egypt

+Investigators

alaa mazy, MD, Study director, faculty of medicine, Mansoura