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Status unknownNCT02154464Updated Jun 3, 2014

Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients

An interventional study of Paracetamol and Placebo in Obesity, sponsored by Soroka University Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-03.

Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Obesity

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Keywords

  • Morphine-sparing
  • Paracetamol
  • Obesity
  • Gastric banding
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 220 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥18 years
  • Patients admitted for laparoscopic gastric banding
  • Elective surgery
  • BMI > 40
  • ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    Paracetamol

    Drug: Paracetamol

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugParacetamol

    Also known as: Perfalgan

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. amount of morphine

    The primary outcome will be the comparison amount of morphine injected in each group until discharge

    Time frame: Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)

Secondary outcomes

  1. 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

    Time frame: Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)

  2. 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)

  3. 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)

  4. Complications during hospitalization.

    Complications during hospitalization, including : * Septic complications * Respiratory, cardiac or other complications

    Time frame: Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)

07

Study locations

1 site
  • Soroka Medical Center, Ben Gurion University of the Negev
    Beer Sheva, Israel
    • Alexander Zlotnik, M.D. Ph.D. · Contact
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02154464
Lead sponsor
Soroka University Medical Center
Responsible party
Alexander Zlotnik (Professor, Soroka University Medical Center) — Principal investigator
First posted
Jun 3, 2014
Start date
Jun 2014
Primary completion
Jun 2016 (estimated)
Last update
Jun 3, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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