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Completed

NCT Number: NCT05317611

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

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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Key information

Conditions

Prevention Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of human medicine, Zagazig university hospitals

El Sharkia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Intraperitoneal instillation of zofran and marcaine

Intravenous ondansetron and intraperitoneal instillation of bupivacaine

Drug

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

Intraperitoneal instillation of bupivacaine

Drug

The aim is to detect effect of intraperitoneal instillation of bupivacaine

Other names: Intraperitoneal instillation of marcaine

Primary outcomes

  1. measure incidence of postoperative nausea and vomiting

    Time frame: 24 hours postoperative

    The number of patient suffering from postoperative nausea and vomiting in each group

  2. measure severity of postoperative nausea and vomiting

    Time frame: 24 hours postoperative

    Simplified Postoperative Nausea and Vomiting Impact Scale (S-PNVIS)

    • *Frequency of Nausea:*
    • 0: None
    • 1: 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: None
    • 1: Once a day
    • 2: 2-3 times a day
    • 3: More than 3 times a day
    • *Impact on Daily Activities:*
    • 0: No impact
    • 1: 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

Secondary outcomes

  1. measure total numbers of rescue antiemetic

    Time frame: all over 24 hours postoperative.

    patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately

  2. Duration of hospital stay

    Time frame: 24 hours to 72 hours

    time from PACU discharge till time to discharge home

  3. postoperative pain by Numerical Rating Scale

    Time frame: 0 hour (basal) in PACU, 2, 4, 8, 12, 24 hours postoperative

    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)

  4. total dose of rescue analgesia postoperative

    Time frame: 24 hours postoperative

    total dose of diclofenac as rescue analgesia postoperative

  5. Patient satisfaction

    Time frame: 24 hours postoperative

    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)

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2022
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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