Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000635369
Ethics application status
Not yet submitted
Date submitted
6/11/2008
Date registered
16/12/2008
Date last updated
16/12/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Reduction of shoulder pain in obese patients undergoing laparoscopic adjustable gastric banding.
Scientific title
A randomized control trial of manual ventilations as a strategy to reduce shoulder pain in obese patients undergoing laparoscopic adjustable gastric banding.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain after laparoscopic adjustable gastric band surgery 3938 0
Condition category
Condition code
Anaesthesiology 4133 4133 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Five manual ventilations administered by anaesthetist at the end of the intra-abdominal phase of laparoscopic gastric band surgery. The anaesthetist will switch the circuit over from ventilator mode to manual mode and administer manual ventilations via the standard 3L bag in the circuit. The intrapulmonary pressure will be monitored via the manometer in the circuit. The five ventilations will be administered sequentially over a 30 second period. The lungs will deflate passively between the administered breaths. We expect this manoeuvre to aid in expulsion of the insufflating carbon dioxide in the peritoneal cavity at the end of surgery before skin closure. A reduced volume of this carbon dioxide may result in less shoulder pain post-operatively.
Intervention code [1] 3652 0
Prevention
Comparator / control treatment
Standard intra-operative and post-operative analgesia. Patients recieve 200 micrograms fentanyl divided between induction and pre-emergence. Parecoxib 40 milligrams intravenous injection (ivi) and paracetamol 1000 milligrams intravenous infusion (ivi) are administered during the maintenance phase of anesthesia. Post operatively in the Post Operative Care Unit a fentanyl pain protocol is employed - 20 micrograms boluses every three minutes (q3min) until pain control or to a maximum of 200 micrograms at which point the anaesthetist is contacted for review and further orders. Once the patient is deemed suitably controlled from their pain, they are released to the Post Operative Surgical ward where a regimen of oral paracetamol, oral non-steroidals and
'as required' oral oxycodone is charted.
Control group
Active

Outcomes
Primary outcome [1] 5023 0
severity of shoulder tip pain by numerical rating scale
Timepoint [1] 5023 0
immediately, one day and 2 weeks post-operative
Secondary outcome [1] 8471 0
Nausea - assessed by verbal self report as none/ mild/ moderate/ severe. These categories will later be assigned simple numerical equivalences ie none = zero, mild = one etc and the groups compared for any differences.
Timepoint [1] 8471 0
immediately and 1 day post-operative

Eligibility
Key inclusion criteria
qualifies for laparoscopic adjustable gastric band surgery, over 18 years old,
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patient does not consent, conversion to open procedure, pre-existing shoulder pain, inability to communicate pain severity, intra-abdominal bleeding or obvious diaphragmatic injury

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Shuffle envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4121 0
Self funded/Unfunded
Name [1] 4121 0
Dr C Taylor
Country [1] 4121 0
Australia
Primary sponsor type
Individual
Name
Dr A Edwards
Address
Sydney Institute for Obesity Surgery (SIOS) Clinic
Sydney Private Hospital
63 Victoria St
Ashfield 2131 NSW
Country
Australia
Secondary sponsor category [1] 3709 0
Individual
Name [1] 3709 0
Dr C Taylor
Address [1] 3709 0
Sydney Institute for Obesity Surgery (SIOS) Clinic
Sydney Private Hospital
63 Victoria St
Ashfield 2131 NSW
Country [1] 3709 0
Australia
Other collaborator category [1] 464 0
Individual
Name [1] 464 0
Dr A Sultana
Address [1] 464 0
Sydney Institute for Obesity Surgery (SIOS) Clinic
Sydney Private Hospital
63 Victoria St
Ashfield 2131 NSW
Country [1] 464 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6193 0
Ethics committee address [1] 6193 0
Ethics committee country [1] 6193 0
Date submitted for ethics approval [1] 6193 0
06/11/2008
Approval date [1] 6193 0
Ethics approval number [1] 6193 0

Summary
Brief summary
The process of laparoscopy can result in shoulder pain post-operatively, apart from what is performed surgically. This pain is thought to be from the gas used to inflate the abdomen. We propose to test a manoeuvre, recently reported to be successful for reducing this pain in another patient group, in our obesity surgery patients. The manoeuvre is a series of five manual "breaths" near the end of surgery which may help to expel the inflating gas from the abdomen, and leave less of the gas to irritate the abdominal lining post operatively, which is felt as shoulder pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29101 0
Address 29101 0
Country 29101 0
Phone 29101 0
Fax 29101 0
Email 29101 0
Contact person for public queries
Name 12258 0
Dr A Edwards
Address 12258 0
Sydney Institute for Obesity Surgery (SIOS) Clinic
Sydney Private Hospital
63 Victoria St
Ashfield 2131 NSW
Country 12258 0
Australia
Phone 12258 0
+61403231305
Fax 12258 0
Email 12258 0
anthonyedwards@people.net.au
Contact person for scientific queries
Name 3186 0
Dr A Edwards
Address 3186 0
Sydney Institute for Obesity Surgery (SIOS) Clinic
Sydney Private Hospital
Ashfield 2131 NSW
Country 3186 0
Australia
Phone 3186 0
+61403231305
Fax 3186 0
Email 3186 0
anthonyedwards@people.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.