Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Condition(s) targeted: Spinal Bupivacaine/Morphine in Laparoscopic Surgery

Intervention: Spinal injection bupivacaine/morphine (Drug); subcutaneum injection lidocaine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Maasstad Hospital

Official(s) and/or principal investigator(s):
AartJan JW Teunissen, MD, Principal Investigator, Affiliation: Maasstad Hospital

Overall contact:
Mark V Koning, MD, Phone: 0031645366134, Email: m.koning@erasmusmc.nl

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.

Official title: Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Duration of hospital stay

Secondary outcome:

use of piritramide by PCIA-pump in mg

patient-satisfactory on a 4-point scale

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

time to mobilisation

time to bowel movement

abdominal compliance during laparoscopy in L/mmHg

Difficulty of 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Laparoscopic Gastro-intestinal surgery

Exclusion Criteria:

- Bariatric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation

disorders, emergency surgery

Mark V Koning, MD, Phone: 0031645366134, Email: m.koning@erasmusmc.nl

Maasstad Hospital, Rotterdam 3079DZ, Netherlands; Recruiting
Sciencebureau, Phone: 31102913357, Email: wetenschapsbureau@maasstadziekenhuis.nl
Mark V. Koning, MD, Principal Investigator

Starting date: August 2014
Last updated: November 3, 2014