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Clinical Trials/NCT02284282
NCT02284282
Completed
Not Applicable

Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Maasstad Hospital1 site in 1 country56 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Spinal injection bupivacaine/morphine
Conditions
Spinal Bupivacaine/Morphine in Laparoscopic Surgery
Sponsor
Maasstad Hospital
Enrollment
56
Locations
1
Primary Endpoint
Duration of hospital stay
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
November 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Maasstad Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Laparoscopic Gastro-intestinal surgery

Exclusion Criteria

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

Arms & Interventions

Spinal injection

Patients receive spinal injection Bupivacaine/Morphine

Intervention: Spinal injection bupivacaine/morphine

Subcutaneum injection

Placebo subcutaneum injections

Intervention: subcutaneum injection lidocaine

Outcomes

Primary Outcomes

Duration of hospital stay

Time Frame: first 48 hours

Secondary Outcomes

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

Study Sites (1)

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