Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Not Applicable

Completed

• Conditions: Spinal Bupivacaine/Morphine in Laparoscopic Surgery
• Interventions: Drug: Spinal injection bupivacaine/morphine; Drug: subcutaneum injection lidocaine

• Registration Number: NCT02284282
• Lead Sponsor: Maasstad Hospital

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Laparoscopic Gastro-intestinal surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal injection	Spinal injection bupivacaine/morphine	Patients receive spinal injection Bupivacaine/Morphine
Subcutaneum injection	subcutaneum injection lidocaine	Placebo subcutaneum injections

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	first 48 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands