Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.
- Conditions
- Prevention
- Interventions
- Drug: Intraperitoneal instillation of ondansetron and bupivacaineDrug: Intravenous ondansetron and intraperitoneal instillation of bupivacaineDrug: Intraperitoneal instillation of bupivacaine
- Registration Number
- NCT05317611
- Lead Sponsor
- Zagazig University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 63
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intraperitoneal instillation of ondansetron and bupivacaine (group A) Intraperitoneal instillation of ondansetron and bupivacaine 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. Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B) Intravenous ondansetron and intraperitoneal instillation of bupivacaine 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. Intraperitoneal instillation of bupivacaine (group C) Intraperitoneal instillation of bupivacaine 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.
- Primary Outcome Measures
Name Time Method measure incidence of postoperative nausea and vomiting 24 hours postoperative The number of patient suffering from postoperative nausea and vomiting in each group
measure severity of postoperative nausea and vomiting 24 hours postoperative 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
- Secondary Outcome Measures
Name Time Method 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
postoperative pain by Numerical Rating Scale 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)
total dose of rescue analgesia postoperative 24 hours postoperative total dose of diclofenac as rescue analgesia postoperative
Patient satisfaction 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)
Trial Locations
- Locations (1)
faculty of human medicine, Zagazig university hospitals
🇪🇬El sharkia, Egypt