Spinal Bupivacaine/Morphine in Laparoscopic SurgerySalmonNCT02284282
Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery
A study testing Spinal injection bupivacaine/morphine and subcutaneum injection lidocaine in people with Spinal Bupivacaine/Morphine in Laparoscopic Surgery, run by Maasstad Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Bupivacaine/Morphine in Laparoscopic Surgery
- What is being tested?
- Spinal injection bupivacaine/morphine and subcutaneum injection lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic Gastro-intestinal surgery
Who cannot join
- Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Spinal injection bupivacaine/morphine, subcutaneum injection lidocaine
- Keywords
- Spinal Morphine, Laparoscopic GI-surgery, Post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal injection bupivacaine/morphineDrug
Also called injection
Spinal injection bupivacaine/morphine in laparoscopic surgery
subcutaneum injection lidocaineDrug
Also called placebo
placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Spinal injection | Active comparator | Patients receive spinal injection Bupivacaine/Morphine Receives: Drug: Spinal injection bupivacaine/morphine |
| Subcutaneum injection | Placebo comparator | Placebo subcutaneum injections Receives: Drug: subcutaneum injection lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Measured: first 48 hours
Secondary outcomes (7)
use of piritramide by PCIA-pump in mg
Measured: 48 hours
patient-satisfactory on a 4-point scale
Measured: 120 hours/ 5 days
the occurence of side-effects (nausea, pruritus, drowsiness)
Measured: 120 hours/ 5 days
time to mobilisation
Measured: 120 hours/ 5 days
time to bowel movement
Measured: 120 hours/ 5 days
abdominal compliance during laparoscopy in L/mmHg
Measured: The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
Difficulty of surgery
Measured: The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Bupivacaine/Morphine in Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AartJan JW Teunissen, MD, Principal investigator, Maasstad HospitalMark V Koning, MD, Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284282
- Sponsor's protocol ID
- NL43488.101.13
- Acronym
- Salmon
- Status last verified
- Dec 2016
- First submitted
- 17 Oct 2014
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29219935
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery
- ClinicalTrials.gov ID
- NCT02284282
- Acronym / sponsor ID
- Salmon / NL43488.101.13
- Keywords
- Spinal Morphine, Laparoscopic GI-surgery, Post-operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal injection | Active comparator | Drug: Spinal injection bupivacaine/morphinePatients receive spinal injection Bupivacaine/Morphine |
| Subcutaneum injection | Placebo comparator | Drug: subcutaneum injection lidocainePlacebo subcutaneum injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laparoscopic Gastro-intestinal surgery
Key exclusion criteria (1 listed)
- Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal injection bupivacaine/morphineAlso: injectionSpinal injection bupivacaine/morphine in laparoscopic surgery | Drug | Spinal injection |
| subcutaneum injection lidocaineAlso: placeboplacebo injection | Drug | Subcutaneum injection |
Primary outcome
Duration of hospital stay
Time frame: first 48 hours
7 secondary outcomes
use of piritramide by PCIA-pump in mg
Time frame: 48 hours
patient-satisfactory on a 4-point scale
Time frame: 120 hours/ 5 days
the occurence of side-effects (nausea, pruritus, drowsiness)
Time frame: 120 hours/ 5 days
time to mobilisation
Time frame: 120 hours/ 5 days
time to bowel movement
Time frame: 120 hours/ 5 days
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.
Difficulty of surgery
Time frame: The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 29219935Koning 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AartJan JW Teunissen, MD principal investigator
Maasstad Hospital
Mark V Koning, MD principal investigator
Maasstad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal injection bupivacaine/morphine and subcutaneum injection lidocaine in people with Spinal Bupivacaine/Morphine in Laparoscopic Surgery, run by Maasstad Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: first 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.