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CompletedNCT02284282SalmonUpdated Aug 8, 2018

Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

An interventional study of Spinal injection bupivacaine/morphine and subcutaneum injection lidocaine in Spinal Bupivacaine/Morphine in Laparoscopic Surgery, sponsored by Maasstad Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Maasstad Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Spinal Bupivacaine/Morphine in Laparoscopic Surgery

Keywords

  • Spinal Morphine
  • Laparoscopic GI-surgery
  • Post-operative pain
03

In context

Lead sponsor

Maasstad Hospital is the lead sponsor of 21 studies on the registry; 5 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
No

Inclusion criteria

  • Laparoscopic Gastro-intestinal surgery

Exclusion criteria

Exclusion Criteria:

  • Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Spinal injection

    Patients receive spinal injection Bupivacaine/Morphine

    Drug: Spinal injection bupivacaine/morphine

  • Placebo comparator
    Subcutaneum injection

    Placebo subcutaneum injections

    Drug: subcutaneum injection lidocaine

Interventions

  • DrugSpinal injection bupivacaine/morphine

    Spinal injection bupivacaine/morphine in laparoscopic surgery

    Also known as: injection

  • Drugsubcutaneum injection lidocaine

    placebo injection

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. Duration of hospital stay

    Time frame: first 48 hours

Secondary outcomes

  1. use of piritramide by PCIA-pump in mg

    Time frame: 48 hours

  2. patient-satisfactory on a 4-point scale

    Time frame: 120 hours/ 5 days

  3. the occurence of side-effects (nausea, pruritus, drowsiness)

    Time frame: 120 hours/ 5 days

  4. time to mobilisation

    Time frame: 120 hours/ 5 days

  5. time to bowel movement

    Time frame: 120 hours/ 5 days

  6. 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.

  7. Difficulty of surgery

    Time frame: The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours

07

Study locations

1 site
  • Maasstad Hospital
    Rotterdam, 3079DZ, Netherlands
08

References and documents

Publications

  • Koning MV, Teunissen AJW, van der Harst E, Ruijgrok EJ, Stolker RJ. Intrathecal Morphine for Laparoscopic Segmental Colonic Resection as Part of an Enhanced Recovery Protocol: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):166-173. doi: 10.1097/AAP.0000000000000703. PubMed 29219935 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02284282
Lead sponsor
Maasstad Hospital
Responsible party
Sponsor
First posted
Nov 6, 2014
Start date
Aug 2014
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Aug 8, 2018

Study contacts

AartJan JW Teunissen, MD
principal investigator · Maasstad Hospital
Mark V Koning, MD
principal investigator · Maasstad Hospital

Oversight

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

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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