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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2022

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.

Interventions

  • 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
  • Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine
    • The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting
  • Drug: Intraperitoneal instillation of bupivacaine
    • The aim is to detect effect of intraperitoneal instillation of bupivacaine

Arms, Groups and Cohorts

  • Active Comparator: Intraperitoneal instillation of ondansetron and bupivacaine (group A)
    • 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.
  • 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) 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.
  • Sham Comparator: Intraperitoneal instillation of bupivacaine (group C)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • measure incidence and severity of postoperative nausea and vomiting
    • Time Frame: 24 hours postoperative
    • 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.

Secondary Measures

  • measure total numbers of rescue antiemetic
    • Time Frame: all over 24 hours postoperative.
    • patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately
  • Duration of hospital stay
    • Time Frame: 24 hours to 72 hours
    • time from PACU discharge till time to discharge home

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zagazig University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dina Abdelhameed Elsadek Salem, principle investigator – Zagazig University

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