Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

NCT ID: NCT02284282

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Spinal Bupivacaine/Morphine in Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Spinal injection

Patients receive spinal injection Bupivacaine/Morphine

Group Type ACTIVE_COMPARATOR

Spinal injection bupivacaine/morphine

Intervention Type DRUG

Spinal injection bupivacaine/morphine in laparoscopic surgery

Subcutaneum injection

Placebo subcutaneum injections

Group Type PLACEBO_COMPARATOR

subcutaneum injection lidocaine

Intervention Type DRUG

placebo injection

Interventions

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Spinal injection bupivacaine/morphine

Spinal injection bupivacaine/morphine in laparoscopic surgery

Intervention Type DRUG

subcutaneum injection lidocaine

placebo injection

Intervention Type DRUG

Other Intervention Names

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injection placebo

Eligibility Criteria

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Inclusion Criteria

* Laparoscopic Gastro-intestinal surgery

Exclusion Criteria

* Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maasstad Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AartJan JW Teunissen, MD

Role: PRINCIPAL_INVESTIGATOR

Maasstad Hospital

Mark V Koning, MD

Role: PRINCIPAL_INVESTIGATOR

Maasstad Hospital

Locations

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Maasstad Hospital

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 29219935 (View on PubMed)

Related Links

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Other Identifiers

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NL43488.101.13

Identifier Type: -

Identifier Source: org_study_id

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