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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02154464
• Other study ID #: SOR 0024-14 CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 26, 2014
• Last updated: June 2, 2014
• Start date: June 2014

Study information

• Verified date: May 2014
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pain, Postoperative

Intervention

Drug:
• Paracetamol

• Placebo

Locations

Country	Name	City	State
Israel	Soroka Medical Center, Ben Gurion University of the Negev	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of morphine	The primary outcome will be the comparison amount of morphine injected in each group until discharge	Until discharge (participants will be followed for the duration of hospital stay, an expected average of 3 days)	No
Secondary	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	Until discarge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)	No
Secondary	Time discharging from PACU		Until discharge from PACU (participants will be followed for the duration of PACU stay, an expected average of 2 hours)	No
Secondary	Length of hospitalization		Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)	No
Secondary	Complications during hospitalization.	Complications during hospitalization, including : Septic complications; Respiratory, cardiac or other complications	Until discharge from hospital (participants will be followed for the duration of hospital stay, an expected average of 3 days)	No