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

Sponsor

Zagazig University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05317611

Collaborator

(none)

Enrollment

Arms

6.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Prevention	Drug: Intraperitoneal instillation of ondansetron and bupivacaine Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine Drug: Intraperitoneal instillation of bupivacaine	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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) 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 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
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.	Drug: Intraperitoneal instillation of bupivacaine The aim is to detect effect of intraperitoneal instillation of bupivacaine Other Names: Intraperitoneal instillation of marcaine

Arm

Intervention/Treatment

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.

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) 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

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

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.

Drug: Intraperitoneal instillation of bupivacaine

The aim is to detect effect of intraperitoneal instillation of bupivacaine

Other Names:

Intraperitoneal instillation of marcaine

Outcome Measures

Primary Outcome Measures

measure incidence and severity of postoperative nausea and vomiting [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina Abdelhameed Elsadek Salem, principle investigator, Zagazig University

ClinicalTrials.gov Identifier:

NCT05317611

Other Study ID Numbers:

9286-23-2-2022

First Posted:

Apr 8, 2022

Last Update Posted:

Apr 8, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vomiting

Ondansetron

Bupivacaine

Study Results

No Results Posted as of Apr 8, 2022