ObesityNCT02154464
Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients
A study testing Paracetamol in people with Obesity, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to Jun 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients admitted for laparoscopic gastric banding
- Elective surgery
- BMI > 40
- ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2
Who cannot join
- Patients' refusal to participate in the study
- Patients unable to give an informed consent
- Pregnancy
- Emergent surgery
- Patient with known allergy to morphine or paracetamol
- Patient with hepatic failure (based on history or elevated liver enzymes).
- ASA class >2.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka Medical Center, Ben Gurion University of the Negev
Beersheba
Alexander Zlotnik, M.D. Ph.D.
About this study
The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.
Read the detailed description
This study is designed as a population-based prospective, double blind cohort study. A prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity
STUDY GOALS
- To evaluate the morphine-sparing effect of paracetamol IV in obese patients undergoing bariatric surgery.
- To identify potential ability of paracetamol IV to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery
- To determine effectiveness of paracetamol IV to reduce postoperative complication rate.
- Conditions
- Obesity
- Being tested
- Paracetamol, Placebo
- Keywords
- Morphine-sparing, Paracetamol, Obesity, Gastric banding
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Not described Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of morphine
The primary outcome will be the comparison amount of morphine injected in each group until discharge
Measured: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Secondary outcomes (4)
Complication during treatment of patient in PACU:
Complication during treatment of patient in PACU, including:
- Respiratory complications (respiratory support, need for ICU, etc)
- Cardiovascular complications (hemodynamic instability, inotropic support )
- Gastrointestinal complications (nausea and vomiting tested by PONV scale, need to use antiemetic drugs)
- Incidence of urinary retention and need for catheterization
- Pruritus
Measured: Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Time discharging from PACU
Measured: Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Length of hospitalization
Measured: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Complications during hospitalization.
Complications during hospitalization, including :
- Septic complications
- Respiratory, cardiac or other complications
Measured: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Zlotnik, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154464
- Sponsor's protocol ID
- SOR 0024-14 CTIL
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Semyonov M, Bartulovic A, Cohen N, Berzon B, Fedorina E, Lerman S, Semionov A, Friger M, Acker A, Geftler A, Zlotnik A, Brotfain E. The effect of timing of intravenous paracetamol on perioperative pain and cytokine levels following laparoscopic bariatric surgery, a randomized controlled trial. Obesity (Silver Spring). 2022 Nov;30(11):2185-2193. doi: 10.1002/oby.23545. Epub 2022 Sep 25.
PubMed 36161276
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT02154464
- Acronym / sponsor ID
- SOR 0024-14 CTIL
- Conditions
- Obesity
- Keywords
- Morphine-sparing, Paracetamol, Obesity, Gastric banding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- 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 investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.
Detailed description
This study is designed as a population-based prospective, double blind cohort study. A prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity
STUDY GOALS
- To evaluate the morphine-sparing effect of paracetamol IV in obese patients undergoing bariatric surgery.
- To identify potential ability of paracetamol IV to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery
- To determine effectiveness of paracetamol IV to reduce postoperative complication rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: Paracetamol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patients admitted for laparoscopic gastric banding
- Elective surgery
- BMI > 40
- ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2
Key exclusion criteria (7 listed)
- Patients' refusal to participate in the study
- Patients unable to give an informed consent
- Pregnancy
- Emergent surgery
- Patient with known allergy to morphine or paracetamol
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 |
|---|---|---|
| ParacetamolAlso: Perfalgan | Drug | Paracetamol |
| Placebo | Drug | Placebo |
Primary outcome
amount of morphine
Time frame: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)
The primary outcome will be the comparison amount of morphine injected in each group until discharge
4 secondary outcomes
Complication during treatment of patient in PACU:
Time frame: Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Time discharging from PACU
Time frame: Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)
Length of hospitalization
Time frame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Complications during hospitalization.
Time frame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
- Derived from this study: PubMed 36161276Semyonov M, Bartulovic A, Cohen N, Berzon B, Fedorina E, Lerman S, Semionov A, Friger M, Acker A, Geftler A, Zlotnik A, Brotfain E. The effect of timing of intravenous paracetamol on perioperative pain and cytokine levels following laparoscopic bariatric surgery, a randomized controlled trial. Obesity (Silver Spring). 2022 Nov;30(11):2185-2193. doi: 10.1002/oby.23545. Epub 2022 Sep 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Obesity, run by Soroka University Medical Center at 1 site in Israel.
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 5 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 3 Jun 2014. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of morphine (time frame: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02154464, which also lists 1 linked publication.
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 3 Jun 2014.