Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

Postoperative Pain Clinical Trial

Official title:

Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05801900
• Other study ID #: MS-340-2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: Maha Mostafa
• Phone: 01000365115
• Email: maha.mostafa[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.

Description:

Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 5 mg dexamethasone drugs.

Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Fentanyl boluses of 1 mcg/kg will be given if heart rate or/and systolic blood pressure >120% of baseline.

Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 4, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous nalbuphine 0.1-0.2 mg/kg (lean body weight) titrated to response with maximum single dose of 20 mg and maximum daily dose of 160 mg.

Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult (18-65 years) patients

• body mass index =35 kg/m2

• scheduled for laparoscopic bariatric surgery

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) physical class IV,

• severe cardiac comorbidity (impaired contractility with ejection fraction < 50%, heart block, significant arrhythmias, tight valvular lesions),

• known obstructive sleep apnea or patients with STOP-bang score =5,

• baseline SpO2 <95%,

• renal impairment,

• allergy to any of study's drugs,

• history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketorolac group
30 min preoperatively then every 8 hours postoperatively
• Ibuprofen group
30 min preoperatively then every 8 hours postoperatively

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual analogue scale	30 minutes after extubation
Secondary	total intraoperative fentanyl	mcg	30 seconds after skin incision until 1 min after skin closure
Secondary	post operative nalbuphine	mg	30 minutes after extubation until 24 hours postoperatively
Secondary	VAS	Visual analogue scale	at 0.5, 4, 10, 18, and 24 hours after extubation
Secondary	time to independent movement	defined as time from extubation to be able independently mobile e.g. using the bathroom	30 minutes after extubation until 24 hours postoperatively