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Completed

NCT Number: NCT02284282

Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

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.

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Key information

Conditions

Spinal Bupivacaine/Morphine in Laparoscopic Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maasstad Hospital

Rotterdam, 3079DZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Laparoscopic Gastro-intestinal surgery

Exclusion criteria

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

Treatment and study plan

Spinal injection bupivacaine/morphine

Drug

Spinal injection bupivacaine/morphine in laparoscopic surgery

Other names: injection

subcutaneum injection lidocaine

Drug

placebo injection

Other names: placebo

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

Sponsors and collaborators

Lead sponsor

Maasstad Hospital

Other

Registry information

Acronym: Salmon

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2014
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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