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

Zagazig University

Status: Completed

Conditions: Prevention

Treatments: Drug: Intraperitoneal instillation of ondansetron and bupivacaine; Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine; Drug: Intraperitoneal instillation of bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05317611

9286-23-2-2022

Details and patient eligibility

About

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 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.

Enrollment: 63 patients

Sex: Female

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups

Intraperitoneal instillation of ondansetron and bupivacaine (group A)

Active Comparator group

Description:

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.

Treatment:

Drug: Intraperitoneal instillation of ondansetron and bupivacaine

Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous ondansetron and intraperitoneal instillation of bupivacaine

Intraperitoneal instillation of bupivacaine (group C)

Active Comparator group

Description:

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.

Treatment:

Drug: Intraperitoneal instillation of bupivacaine