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

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

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.

Study Overview

• Status: Completed
• Conditions: Prevention
• Intervention / Treatment: Drug: Intraperitoneal instillation of ondansetron and bupivacaine; Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine; Drug: Intraperitoneal instillation of bupivacaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El sharkia, Egypt
    • faculty of human medicine, Zagazig university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Written informed consent from the patient.
• Age: 21-60 years old.
• female patients
• Physical status: ASA 1& II.
• BMI = ≤ 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.
• hepatic, renal impairment or disease , 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intraperitoneal instillation of ondansetron and bupivacaine (group A); 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.	Drug: Intraperitoneal instillation of ondansetron and bupivacaine; The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting; Other Names: Intraperitoneal instillation of zofran and marcaine
Active Comparator: Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B); 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.	Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine; The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting; Other Names: Intravenous zofran and intraperitoneal instillation of marcaine
Active Comparator: Intraperitoneal instillation of bupivacaine (group C); 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.	Drug: Intraperitoneal instillation of bupivacaine; The aim is to detect effect of intraperitoneal instillation of bupivacaine; Other Names: Intraperitoneal instillation of marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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); *Frequency of Nausea:*0: None1: Occasionally (1-2 times a day)2: Frequently (3-4 times a day)3: Constantly (more than 4 times a day); *Frequency of Vomiting:*0: None1: Once a day2: 2-3 times a day3: More than 3 times a day; *Impact on Daily Activities:*0: No impact1: Mild impact (able to perform most activities)2: Moderate impact (some activities limited)3: Severe impact (most activities limited)#Scoring*Total Score:* Sum of scores from all 3 items.*Interpretation:* Higher total scores indicate a greater impact of nausea and vomiting on the patient recovery	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
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

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 26, 2025

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: ondansetron; postoperative nausea and vomiting; intraperitoneal instillation; laparoscopic gynecological surgeries
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Bupivacaine; Ondansetron
• Other Study ID Numbers: 9286-23-2-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No