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Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting.
There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain).
Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal instillation of ondansetron and bupivacaine (group A) | Active Comparator | Patients will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. |
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| Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B) | Active Comparator | Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. |
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| Intraperitoneal instillation of bupivacaine (group C) | Active Comparator | patient will receive intraperitoneal instillation of (100 mg) 40 ml of bupivacaine 0.25 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal instillation of ondansetron and bupivacaine | Drug | The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting |
| Measure | Description | Time Frame |
|---|---|---|
| measure incidence of postoperative nausea and vomiting | The number of patient suffering from postoperative nausea and vomiting in each group | 24 hours postoperative |
| measure severity of postoperative nausea and vomiting | Simplified Postoperative Nausea and Vomiting Impact Scale (S-PNVIS)
| 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| measure total numbers of rescue antiemetic | patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately | all over 24 hours postoperative. |
| Duration of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of human medicine, Zagazig university hospitals | El Sharkia | Egypt |
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Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic gynecological surgeries.
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Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters
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| Intravenous ondansetron and intraperitoneal instillation of bupivacaine | Drug | The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting |
|
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| Intraperitoneal instillation of bupivacaine | Drug | The aim is to detect effect of intraperitoneal instillation of bupivacaine |
|
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time from PACU discharge till time to discharge home
| 24 hours to 72 hours |
| postoperative pain by Numerical Rating Scale | 10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain) | 0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative |
| total dose of rescue analgesia postoperative | total dose of diclofenac as rescue analgesia postoperative | 24 hours postoperative |
| Patient satisfaction | degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia) | 24 hours postoperative |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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