Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000262606
Ethics application status
Approved
Date submitted
26/02/2014
Date registered
11/03/2014
Date last updated
11/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound guided Transversus Abdominis Plane block: An evaluation of its efficacy in reducing post-op opioid requirements in Caesarean section
Scientific title
Parturients undergoing elective Caesarean section, Transversus Abdominis Plane block compared to intravenous Morphine via Patient Controlled Analgesia PCA to achieve better Postoperative pain control.
Secondary ID [1] 284114 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management after Caesarean section 291191 0
Condition category
Condition code
Anaesthesiology 291526 291526 0 0
Pain management
Reproductive Health and Childbirth 291695 291695 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
patients will receive TAP block, 0.25% Bupivacaine 20 ml bilaterally along with PCA Morphine

Arm 2
patients will receive TAP block, 0.166% bupivacaine 30 ml bilaterally along with PCA Morphine

TAP block is administered immediatly post caesarean section after skin suturing.
PCA Morphine is made available in immediate post operative period in recovery room.

PCA 1mg morphine per dose. lockout interval of 5 minutes. no background infusion and Maximum of 30 mg morphine per 4 hours.
Intervention code [1] 288806 0
Treatment: Drugs
Comparator / control treatment
patients will receive only conventional analgesia via PCA morphine. It will be available immediately after surgery in the recovery room. 1 mg of morphine can be given per dose. no background infusion. lockout interval of 5 minutes and maximum 4 hours dose of 30 mg.
Control group
Active

Outcomes
Primary outcome [1] 291503 0
total morphine consumption in the first 24 hour
Timepoint [1] 291503 0
24 hours
Secondary outcome [1] 306913 0
post op for pain score using the visual analogue scale
Timepoint [1] 306913 0
0, 6, 12 and 24 hours post operative
Secondary outcome [2] 306914 0
Sedation scores using Richmond Agitation Sedation Scale (RASS]
Timepoint [2] 306914 0
0, 6, 12 and 24 hours post operative
Secondary outcome [3] 306917 0
Post Operative Nausea and Vomiting PONV.
It is a yes/no outcome.
Timepoint [3] 306917 0
0, 6, 12 and 24 hours post operative

Eligibility
Key inclusion criteria
Elective caesarean section.

ASA 1 and ASA 2 patients.

Patients receiving Spinal anaesthesia for surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency caesarean sections.
ASA 3 and ASA 4 patients.
Morbidly Obese patients.
Patients with local anaesthesia allergy

Study design
Purpose of the study
Treatment
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)
The closed envelopes contains the assigned plan of management. the envelops
method of randomisation is simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
22/06/2013
Date of last participant enrolment
Anticipated
1/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5841 0
Bahrain
State/province [1] 5841 0

Funding & Sponsors
Funding source category [1] 288752 0
Hospital
Name [1] 288752 0
King Hamad University Hospital
Country [1] 288752 0
Bahrain
Primary sponsor type
Individual
Name
Shahid Adeel
Address
King Hamad University Hospital, Anaesthesia department KHUH, Al Muharraq PO box 24343
Country
Bahrain
Secondary sponsor category [1] 287448 0
Hospital
Name [1] 287448 0
Anaesthesia department KHUH
Address [1] 287448 0
King Hamad University Hospital, Anaesthesia department KHUH, Al Muharraq. PO box 24343
Country [1] 287448 0
Bahrain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290592 0
Research and Ethics Committee of King Hamad University Hospital.
Ethics committee address [1] 290592 0
Research and Ethics Committee of KHUH. Al Muharraq.
PO box 24343
Ethics committee country [1] 290592 0
Bahrain
Date submitted for ethics approval [1] 290592 0
Approval date [1] 290592 0
18/06/2013
Ethics approval number [1] 290592 0

Summary
Brief summary
The transversus abdominis plane (TAP) block is a new regional anaesthesia technique that provides analgesia to the peritoneum, skin as well as the muscles of the anterior abdominal wall. It is easy to perform with a high margin of safety, especially under ultrasound guidance.

TAP blocks have been described as an effective component of multimodal postoperative analgesia for a wide variety of abdominal procedures including caesarean section. Current reports demonstrated its safety and efficacy in reducing opioids consumption. Post-op analgesia in patient undergoing emergency caesarean section has conventionally been a multi-modal analgesia comprising of morphine PCA, regular paracetamol and NSAIDs. These have resulted in large consumption of morphine which is excreted via breast milk. These also result in higher sedation score and higher incidence of post operative nausea and vomiting
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46310 0
Dr Shahid Adeel
Address 46310 0
King Hamad University Hospital, Anaesthesia department. Al Muharraq. PO box 24343
Country 46310 0
Bahrain
Phone 46310 0
+97333301673
Fax 46310 0
Email 46310 0
[email protected]
Contact person for public queries
Name 46311 0
Dr Shahid Adeel
Address 46311 0
King Hamad University Hospital, Anaesthesia department. Al Muharraq PO box 24343
Country 46311 0
Bahrain
Phone 46311 0
+97333301673
Fax 46311 0
Email 46311 0
[email protected]
Contact person for scientific queries
Name 46312 0
Dr shahid Adeel
Address 46312 0
King Hamad University Hospital, Anaesthesia department. Al Muharraq PO box 24343
Country 46312 0
Bahrain
Phone 46312 0
+97333301673
Fax 46312 0
Email 46312 0
[email protected]

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.