Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery (Salmon)

August 6, 2018 updated by: Maasstad Hospital
The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal with bupicavaine/morphine will result in a better analgesia in hte first 48 hours. Herby the patients will require less systemic opioids, which will decrease the side-effects. Furthermore, we expect the patients to recover quicker and show an earlier mobilisation and a shorter hospital stay.

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3079DZ
        • Maasstad Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Laparoscopic Gastro-intestinal surgery

Exclusion Criteria:

  • Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spinal injection
Patients receive spinal injection Bupivacaine/Morphine
Drug: Spinal injection bupivacaine/morphine
Spinal injection bupivacaine/morphine in laparoscopic surgery
Other Names:
  • injection
Placebo Comparator: Subcutaneum injection
Placebo subcutaneum injections
Drug: subcutaneum injection lidocaine
placebo injection
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of hospital stay
Time Frame: first 48 hours
first 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
use of piritramide by PCIA-pump in mg
Time Frame: 48 hours
48 hours
patient-satisfactory on a 4-point scale
Time Frame: 120 hours/ 5 days
120 hours/ 5 days
the occurence of side-effects (nausea, pruritus, drowsiness)
Time Frame: 120 hours/ 5 days
120 hours/ 5 days
time to mobilisation
Time Frame: 120 hours/ 5 days
120 hours/ 5 days
time to bowel movement
Time Frame: 120 hours/ 5 days
120 hours/ 5 days
abdominal compliance during laparoscopy in L/mmHg
Time Frame: The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
Difficulty of surgery
Time Frame: The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours
The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maasstad Hospital

Investigators

  • Principal Investigator: AartJan JW Teunissen, MD, Maasstad Hospital
  • Principal Investigator: Mark V Koning, MD, Maasstad Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL43488.101.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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