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Trial registered on ANZCTR


Registration number
ACTRN12613001330730
Ethics application status
Approved
Date submitted
22/10/2013
Date registered
3/12/2013
Date last updated
3/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transversus abdominis plane block, paravertebral block and postoperative analgesia in patients undergoing inguinal hernia surgery
Scientific title
Comparative effects of transversus abdominis plane and paravertebral block on postoperative pain in inguinal hernia surgery
Secondary ID [1] 283435 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain 290347 0
inguinal hernia 290368 0
Condition category
Condition code
Anaesthesiology 290744 290744 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The heart rates (3-channel electrocardiograms), noninvasive blood pressure and peripheral oxygen saturation (SpO2) of all the patients were monitored. Thirty minutes before the induction of anaesthesia midazolam (1–2 mg) was administered IV as premedication. Before spinal anaesthesia, for postoperative analgesia, Group T received TAP block under ultrasonographic guidance, and Group P underwent PVB in combination with nerve stimulation. Investigators’s prior experience with both these techniques were enough (They did at least 80 times).

For the transversus abdominis plane (TAP) block, a linear ultrasound (US) probe (6–13 MHz) (Logiq book XP, GE Medical Systems, China) and an 80 mm 22 G (Uniplex Nanoline, Pajunk, Germany)

needle were used. As local anaesthetic, 0.5% bupivacaine (1.5 mg/kg, diluted to 20 ml with normal saline) was preferred.

For the paravertebral block (PVB), a nerve stimulator (Stimuplex (registered trademark), B. Braun AG, Melsungen, Germany) was applied at the T11–12 and the L1 vertebral levels using an 80 mm 22 G (Uniplex Nanoline) needle. The stimulator was set at 2 mA, 9 V, 2 Hz for 0.1 msec. After insertion of the needle through the skin, contractions of the paraspinous muscle occur. When the paravertebral space is entered, these contractions disappear, and they are seen in the lower abdominal and inguinal regions. In the current study, when the contractions were observed at 0.8 mA, a local anaesthetic drug (0.5% bupivacaine, 5 ml at every level) was injected.
We confirmed that the blocks with the icepack test. Both block success was 100%. Then the patients were positioned in the lateral decubitus position, and the L4–L5 interspinous space was entered with a 25 G Quincke needle. Spinal anaesthesia was administered using 10–12.5 mg heavy bupivacaine + 25 microgram fentanyl. The sensory block was then evaluated using the icepack test, and the operation commenced when the PVB and TAP block extended beyond the vertebral T9 level and above.

The heart rate, noninvasive blood pressure, Sp02 and VAS values were recorded during the preoperative period every 3 min for 15 min and then at 5 min intervals after the induction of spinal anaesthesia. During the postoperative period, when the level of spinal anaesthesia dropped below T10, the patients were transferred to their room. During follow-up visits in their room, their blood pressure, heart rates and VAS values were recorded at 1 and 30 min and at 1, 3, 6, 12 and 24 h. If the VAS score was between
3 and 5, 75 mg IM diclofenac sodium were injected. If it was above 5 points, this was


proceeded by 75 mg IM diclofenac Na. If this was ineffective within 30 min, an additional 25 mg IM meperidine were administered. When the SpO2 dropped below
95% during the intraoperative and recovery periods, oxygen was delivered by a face mask at a rate of 2–3 L min-1. When the mean arterial pressure dropped below 65 mm Hg, 5–10 mg IV ephedrine were injected. Intraoperative and postoperative complications and the treatment modalities were recorded. The type of surgery in both groups is used Lichtenstein's tension free technique.
Intervention code [1] 288155 0
Treatment: Other
Intervention code [2] 288165 0
Treatment: Drugs
Comparator / control treatment
The patients were divided into two groups. Patients were used TAP block (Group T) or PVB (Group P).
Control group
Active

Outcomes
Primary outcome [1] 290743 0
Postoperative pain as assessed by VAS values.
Timepoint [1] 290743 0
The postoperative period were recorded at 1 and 30 min and at 1, 3, 6, 12 and 24 h.
Primary outcome [2] 290753 0
analgesic consumption
Timepoint [2] 290753 0
intraoperative and postoperative period (up to 24h)
Secondary outcome [1] 305146 0
The heart rate
Timepoint [1] 305146 0
The heart rate values were recorded during the preoperative period, every 3 min for 15 min and then at 5 min intervals after the induction of spinal anaesthesia until the end surgery. During the postoperative period,their heart rates were recorded at 1 and 30 min and at 1, 3, 6, 12 and 24 h.
these outcomes were assessed by ECG
Secondary outcome [2] 305174 0
noninvasive blood pressure
Timepoint [2] 305174 0
values were recorded during the preoperative period, every 3 min for 15 min and then at 5 min intervals after the induction of spinal anaesthesia until the end of surgery. During the postoperative period,their blood pressure were recorded at 1 and 30 min and at 1, 3, 6, 12 and 24 h.
these outcomes were assessed by automatic sphygmomanometer
Secondary outcome [3] 305175 0
Sp02 values
Timepoint [3] 305175 0
Sp02 values were recorded during the preoperative period, every 3 min for 15 min and then at 5 min intervals after the induction of spinal anaesthesiauntil the end of surgery.
these outcomes were assessed by pulse oximetry.
Secondary outcome [4] 305176 0
operative time
Timepoint [4] 305176 0
operative period is from induction of spinal anaesthesia until closure of incision.
Secondary outcome [5] 305177 0
complications:
1-Hypoxi; when the SpO2 dropped below
95% during the intraoperative and recovery periods.
2- Hypotension; when the mean arterial pressure dropped below 65 mm Hg.
3-Bradycardia; when the heart rate dropped below 50 beats per minute.
Timepoint [5] 305177 0
intraoperative period and postoperatif period (up to 24h)

Eligibility
Key inclusion criteria
1-American Society of Anesthesiologists (ASA) risk scores of I–III
2-Patients were scheduled to undergo elective unilateral inguinal hernia repair
Minimum age
19 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who did not volunteer to participate in the study, had BMIs >/=40 kg/m 2, had an infection at the site of the intervention or who had hepatic or renal failure were not included in the study. Additional exclusion criteria were patients in whom local anaesthetic, sodium diclofenac or meperidine were contraindicated.

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)
with sealed envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/11/2012
Actual
30/11/2012
Date of last participant enrolment
Anticipated
15/02/2013
Actual
1/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5530 0
Turkey
State/province [1] 5530 0
samsun

Funding & Sponsors
Funding source category [1] 288153 0
Self funded/Unfunded
Name [1] 288153 0
CENGIZ KAYA
Country [1] 288153 0
Turkey
Primary sponsor type
Individual
Name
CENGIZ KAYA
Address
ondokuz mayis university faculty of medicine kurupelit/atakum/samsun/turkey postcode: 55139
Country
Turkey
Secondary sponsor category [1] 286875 0
None
Name [1] 286875 0
Address [1] 286875 0
Country [1] 286875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290069 0
19 Mayis University Ethics Committee of Clinical Investigations
Ethics committee address [1] 290069 0
Ethics committee country [1] 290069 0
Turkey
Date submitted for ethics approval [1] 290069 0
Approval date [1] 290069 0
18/10/2012
Ethics approval number [1] 290069 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43770 0
Dr cengiz kaya
Address 43770 0
ondokuz mayis university faculty of medicine kurupelit/atakum/samsun/turkey postcode: 55139
Country 43770 0
Turkey
Phone 43770 0
+905056793359
Fax 43770 0
Email 43770 0
raufemre@yahoo.com
Contact person for public queries
Name 43771 0
cengiz kaya
Address 43771 0
ondokuz mayis university faculty of medicine kurupelit/atakum/samsun/turkey postcode: 55139
Country 43771 0
Turkey
Phone 43771 0
+905056793359
Fax 43771 0
Email 43771 0
raufemre@yahoo.com
Contact person for scientific queries
Name 43772 0
cengiz kaya
Address 43772 0
ondokuz mayis university faculty of medicine kurupelit/atakum/samsun/turkey postcode: 55139
Country 43772 0
Turkey
Phone 43772 0
+905056793359
Fax 43772 0
Email 43772 0
raufemre@yahoo.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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