Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study

Conditions
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Prevention

Intervention / Treatment
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* Drug: Intraperitoneal instillation of ondansetron and bupivacaine
* Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine
* Drug: Intraperitoneal instillation of bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent from the patient. Age: 21-45 years old. Both sex. Physical status: ASA 1& II. BMI = (25-35 kg/m2). Type of operation: elective laparoscopic gynecological surgeries. Exclusion Criteria: Altered mental state. Patients with known history of allergy to the study drugs. Advanced hepatic, renal, cardiovascular, and respiratory diseases. Patients with chronic pain received NSAID or opioid during previous two weeks. Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraperitoneal instillation of ondansetron and bupivacaine (group A)<br>Patients will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % 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. | Drug: Intraperitoneal instillation of ondansetron and bupivacaine<br>* The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting<br>* Other names: Intraperitoneal instillation of zofran and marcaine;|
| Active Comparator: Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)<br>Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. | Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine<br>* The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting<br>* Other names: Intravenous zofran and intraperitoneal instillation of marcaine;|
| Sham Comparator: Intraperitoneal instillation of bupivacaine (group C)<br>patient will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA. | Drug: Intraperitoneal instillation of bupivacaine<br>* The aim is to detect effect of intraperitoneal instillation of bupivacaine<br>* Other names: Intraperitoneal instillation of marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure incidence and severity of postoperative nausea and vomiting | using Rohdes Index of Nausea, Vomiting, and Retching it is questionnaire of 8 items with minimum score =0 and maximum score =4 for each item. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | time from PACU discharge till time to discharge home | 24 hours to 72 hours |