Pain, Acute
Conditions
Keywords
cholecystectomy;, analgesia;, gallbladder;, infiltration;, visceral pain
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.
Interventions
DRUGthe infiltration group
* 15-20 ml periportal, * 50 ml in gallbladder bed, * The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
DRUGthe control group
the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.
Sponsors
Alaa Mazy Mazy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
the infiltration cocktail of local anesthetic will be replaced by saline in the same volume.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total postoperative analgesic consumption | postoperative, for 24 hours | ketorolac and morphine in mg . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The time to the first request of analgesia | postoperative, for 24 hours | hours |
| 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. |
| incidence of vomiting | postoperatively, during the first 24 hours | number |
Countries
Egypt
Outcome results
None listed