Postoperative PainNCT05801900
Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery
A study testing Ketorolac group and Ibuprofen group in people with Postoperative Pain and Bariatric Surgery Candidate, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Bariatric Surgery Candidate
- What is being tested?
- Ketorolac group and Ibuprofen group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2023to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (18-65 years) patients
- body mass index ≥35 kg/m2
- scheduled for laparoscopic bariatric surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.
Read the detailed 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
- Conditions
- Postoperative Pain, Bariatric Surgery Candidate
- Being tested
- Ketorolac group, Ibuprofen group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac groupDrug
30 min preoperatively then every 8 hours postoperatively
Ibuprofen groupDrug
30 min preoperatively then every 8 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac group | Active comparator | ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes Receives: Drug: Ketorolac group |
| Ibuprofen group | Active comparator | ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes Receives: Drug: Ibuprofen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analogue scale
Measured: 30 minutes after extubation
Secondary outcomes (4)
total intraoperative fentanyl
mcg
Measured: 30 seconds after skin incision until 1 min after skin closure
post operative nalbuphine
mg
Measured: 30 minutes after extubation until 24 hours postoperatively
VAS
Visual analogue scale
Measured: at 0.5, 4, 10, 18, and 24 hours after extubation
time to independent movement
defined as time from extubation to be able independently mobile e.g. using the bathroom
Measured: 30 minutes after extubation until 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801900
- Sponsor's protocol ID
- MS-340-2022
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data from this study are available from the PI upon resealable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Morbid Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05801900
- Acronym / sponsor ID
- MS-340-2022
- Conditions
- Postoperative Pain, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac group | Active comparator | Drug: Ketorolac groupketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes |
| Ibuprofen group | Active comparator | Drug: Ibuprofen groupibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (18-65 years) patients
- body mass index ≥35 kg/m2
- scheduled for laparoscopic bariatric surgery
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac group30 min preoperatively then every 8 hours postoperatively | Drug | Ketorolac group |
| Ibuprofen group30 min preoperatively then every 8 hours postoperatively | Drug | Ibuprofen group |
Primary outcome
VAS
Time frame: 30 minutes after extubation
Visual analogue scale
4 secondary outcomes
total intraoperative fentanyl
Time frame: 30 seconds after skin incision until 1 min after skin closure
post operative nalbuphine
Time frame: 30 minutes after extubation until 24 hours postoperatively
VAS
Time frame: at 0.5, 4, 10, 18, and 24 hours after extubation
time to independent movement
Time frame: 30 minutes after extubation until 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No. data from this study are available from the PI upon resealable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac group and Ibuprofen group in people with Postoperative Pain and Bariatric Surgery Candidate, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Mostafa (01000365115, maha.mostafa@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 30 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.