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Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.
The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.
-But these methods are not widely used in pediatrics upon our knowledge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chirocaine group (levobupivacaine ) | Active Comparator |
| |
| Control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine 0.5% | Drug | Group I (Chirocaine group) (n=20): Levobupivacaine 0.5% will be instilled during insufflations of CO2 at the beginning of surgery at a dose of 2mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain scoring (CHEOPS) | pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours. | up to six hours |
| Measure | Description | Time Frame |
|---|---|---|
| changes in Haemodynamics including ( Heart Rate) | Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative) | during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Indirect signs of local anaesthetic toxicity (intraoperative arrhythmias and delayed awakening) | From time of instillation of levobupivacaine till 6 hours postoperative. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad El Basha, M.D. | Cairo University | Study Chair |
| Maha Gmail, M.D. | Cairo University | Study Director |
| Sherif M Soaida, M.D. | Cairo University | Study Director |
| hagar H Refaee | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Cairo University | Cairo | 11562 | Egypt |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain |
|
| changes in Haemodynamics including ( Non Invasive Blood Pressure) | Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative) | during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6 |