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

NCT05317611 | Completed

• 1 other identifier: 9286-23-2-2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prevention

Keywords

ondansetron; intraperitoneal instillation; laparoscopic gynecological surgeries; postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (2)

• 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) 1. \*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) 2. \*Frequency of Vomiting:\* * 0: None * 1: Once a day * 2: 2-3 times a day * 3: More than 3 times a day 3. \*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

  24 hours postoperative

Secondary Outcomes (5)

• measure total numbers of rescue antiemetic

  all over 24 hours postoperative.

• Duration of hospital stay

  24 hours to 72 hours

• postoperative pain by Numerical Rating Scale

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

• total dose of rescue analgesia postoperative

  24 hours postoperative

• Patient satisfaction

  24 hours postoperative

Study Arms (3)

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.

Drug: Intraperitoneal instillation of ondansetron and bupivacaine

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.

Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine

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.

Drug: Intraperitoneal instillation of bupivacaine

Interventions

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

Also known as: Intraperitoneal instillation of zofran and marcaine

Intraperitoneal instillation of ondansetron and bupivacaine (group A)

Intravenous ondansetron and intraperitoneal instillation of bupivacaine DRUG

The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting

Also known as: Intravenous zofran and intraperitoneal instillation of marcaine

Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)

Intraperitoneal instillation of bupivacaine DRUG

The aim is to detect effect of intraperitoneal instillation of bupivacaine

Also known as: Intraperitoneal instillation of marcaine

Intraperitoneal instillation of bupivacaine (group C)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of human medicine, Zagazig university hospitals

El Sharkia, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 8, 2022
• Study Start: July 1, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 26, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)