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Trial registered on ANZCTR


Registration number
ACTRN12614000648628
Ethics application status
Approved
Date submitted
7/06/2014
Date registered
18/06/2014
Date last updated
18/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
injection of local anesthetic in the abdominal wall for post-cesarean section pain control
Scientific title
Surgical Transversus Abdominis Plane (TAP) Block for Post-Cesarean Section Pain Control in women
Secondary ID [1] 284758 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post cesarean section pain 292128 0
Condition category
Condition code
Reproductive Health and Childbirth 292462 292462 0 0
Childbirth and postnatal care
Anaesthesiology 292495 292495 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post-operatively, all patients will receive the conventional analgesic methods in the form of combination of non-steroidal inflammatory drugs and paracetamol as post-operative analgesia.
Conventional analgesia will include intravenous diclofenac 75 mg every 12 hours and intravenous paracetamol 1000 mg every 8 hours.
The cases will receive surgical TAP block by the end of Cesarean section after closure of the uterus (bupivacaine 0.25%) in addition to the other conventional analgesics to control post-operative pain.
Control group will receive placebo in the form of 20 ml of normal saline injected in the transversus abdominis plane on both sides.
Opioid analgesics in the form of IM pethidine 100 mg will be given to patients of the two groups when needed.

Technique of the TAP block:
After closure of the uterus, the rectus muscle is elevated superiorly using a retractor. Care should be taken to avoid any damage to the inferior epigastric vessels located at its lateral border. The nerves that supply the anterior abdominal wall travel through the neurofascial plane between internal oblique and transversus abdominis muscles. This plane can be easily be achieved by inserting a (18G) needle through the parietal peritoneum and with further needle advancement there is loss of resistance and the correct plane is entered. After careful aspiration, to ensure there’s no vascular injury, 20 ml 0.25% bupivacaine (50 mg bupivacaine) is introduced slowly. The plane will be expanded after the procedure
Intervention code [1] 289551 0
Treatment: Drugs
Comparator / control treatment
transversus abdominis plane injection of placebo in the form of normal saline.
Control group
Placebo

Outcomes
Primary outcome [1] 292323 0
assessing the pain score in the postoperative period using visual analogue scale
Timepoint [1] 292323 0
6, 12 and 24 hours after cesarean section
Secondary outcome [1] 308717 0
Incidence of Postoperative nausea and vomiting.
Yes/No

Timepoint [1] 308717 0
at 6, 12 and 24 hours after cesarean section
Secondary outcome [2] 308755 0
Early ambulation.
Timepoint [2] 308755 0
patients will be observed during the 24 hours post-operative for the time they move out of their beds or simply change their recumbent position.
Secondary outcome [3] 308756 0
Required doses of opioid analgesics and their adverse effects.
Timepoint [3] 308756 0
the overall dose of intramuscular pethidine required in each patient will be calculated during the 24 hours following cesarean section.
any adverse effects to pethidine use will be observed and recorded, for example itching or vomiting.
Secondary outcome [4] 308757 0
Observe for possible complication for the surgical TAP block, for example anterior abdominal wall hematoma.
Timepoint [4] 308757 0
during the 24 hours following cesarean section, any complication related to local anesthetic injection will be assessed by:
recording blood pressure and peripheral pulse rate continuously during the procedure and for one hour post-injection, then monitoring will be every 6 hours interval.
careful examination of the site of injection for haematoma formation during the procedure, this will be confirmed later by abdominal examination during the early post-operative period.

Eligibility
Key inclusion criteria
Women undergoing Cesarean section under general anesthesia by the researcher.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major systemic diseases, e.g. diabetes mellitus.
- Chronic pain disorders.
- Abuse of drugs or alcohol.
- Allergies to any medication used in the study.
- Patients with bleeding disorders.
- Regional anesthesia including spinal and epidural anesthesia.
- Patients with body mass index more than 35.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated using EpiInfo version 6.0, setting the power (beta) at 80% and alpha error at 0.05.
Confidence interval equals (1-a) = 95%. Risk ratio equals 1.5
Data from a previous study (Owen et al., 2010), indicated that TAP blocks provide postoperative analgesia comparable to that provided by intrathecal diamorphine after caesarean section. Calculation according to these data produced a minimal sample size of 100 cases.

Statistical analysis was done using IBM SPSS Statistics version 21 (IBM Corp., Armonk, NY).
The Shapiro-Wilk test was used to examine the normality of numerical data distribution. Normally distributed numerical data were presented as mean and SD, and differences between the two groups were compared with the independent-samples Student-t test.
Skewed numerical data were presented as median and interquartile range and inter-group differences were compared non-parametrically using the Mann-Whitney U test.
Qualitative data were presented as number and percentage and the chi-square test was applied for comparison of nominal data. Linear-by-linear association was used to compare ordinal data.
P<0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6105 0
Egypt
State/province [1] 6105 0
cairo

Funding & Sponsors
Funding source category [1] 289374 0
Self funded/Unfunded
Name [1] 289374 0
mahmoud yehia ahmed moussa
Address [1] 289374 0
30 El-lewaa Mahmoud Sami Street, 6th district, Nasr City, cairo
Country [1] 289374 0
Egypt
Primary sponsor type
University
Name
Ain Shmas University
Address
Ain Shams University
Obstetrics and Gynecology Department
Abbassya, Cairo
post code 11566
Country
Egypt
Secondary sponsor category [1] 288058 0
None
Name [1] 288058 0
Address [1] 288058 0
Country [1] 288058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291138 0
research ethics committee
Ethics committee address [1] 291138 0
Ain Shams University
Faculty of Medicine
Ahmed Lotfy El-sayed street, Abbassya square
Cairo
post code 11566
Ethics committee country [1] 291138 0
Egypt
Date submitted for ethics approval [1] 291138 0
Approval date [1] 291138 0
14/10/2012
Ethics approval number [1] 291138 0
1362/2012

Summary
Brief summary
Background:
Cesarean section remains by far the most common surgical procedure performed for female population, and for sure post-operative pain is an issue that matters most. In fact, post-operative pain maybe one of the main reasons patients may refuse to do cesarean section. Post-operative analgesia can be provided for the patients in many forms starting from simple parenteral analgesics as NSAID’s and paracetamol up to neuraxial narcotics. Many local techniques have been developed to alleviate post-operative pain, tranversus abdominis plane block is a relatively newly technique that was introduced to control pain after abdominal surgeries. TAP block can be done either transcutaneous using anatomical landmarks or ultrasound guided, or can be done by open surgical technique as described here.

Aim of the work:
This study aims at testing the efficacy of injection of local anesthetic into a particular plane the abdominal wall (the transversus abdominis plane) in order to control the pain after cesarean section.
Study the analgesic effect of the surgical transversus abdominis plane (TAP) block as regard the pain score in the post-operative period in patients undergoing Cesarean section.
Objectives of this study:
*Primary objective: assessing the pain score in the postoperative period either with or without the surgical TAP block.
*Secondary objectives: assessment of:
1-Postoperative nausea and vomiting.
2-Early ambulation.
3-Required doses of opioid analgesics and their adverse effects.
4-Possible complication for the surgical TAP block, for example hypotension, arrhythmia or anterior abdominal wall hematoma.


Patients and methods:
The current study will include 100 women undergoing Cesarean section. The patients will be randomized in 2 groups, Group 1, who will receive surgical TAP block in addition to conventional analgesia (cases) and Group 2, who will receive conventional analgesia plus placebo (control group). The cases will receive surgical TAP block by the end of Cesarean section after closure of the uterus (bupivacaine 0.25%) in addition to the other conventional analgesics to control post-operative pain. Control group will receive placebo in the form of 20 ml of normal saline injected in the transversus abdominis plane on both sides. Comparison between the two groups will include post-operative pain scoring using visual analogue scale at 6, 12 and 24 hours, post-operative nausea and vomiting, side effects of material (pruritis, hypotension or arrhythmia), early ambulation and the required doses of opioid analgesia.

Results:
The pain scores at 6 hours during rest in the surgical TAP group ranged between 40-54 mm, while in the control group, the pain scores ranged between 49-57 mm, with p-value <0.001. This difference is statistically significant, though the difference in the pain scores were not high. Observing pain scores at 12 and 24 hours during rest showed no clinical or statistical difference. The post-operative pain scores during movement at 6 hours in the surgical TAP group ranged between 44-58 mm, while in the control group ranged between 53-61 mm, with P-value <0.001. Pain scores at 12 hours also showed statistical difference (p-value<0.010) with pain scores ranging between 24-33 mm and 22-27 mm in the TAP and control groups respectively. Lastly, pain scores at 24 hours showed no difference between both groups. As regard opioid consumption post-operatively, 11 women from the TAP group requested 1 dose (100 mg) of intramuscular pethidine compared to 21 women from the control group. Furthermore, six cases requested 2 doses (200 mg) of pethidine, two cases in the control group and four cases in the TAP group. Post-operative nausea and vomiting occurred in six women from the TAP group compared to nine women in the control group. No other side effects related to the injection of local anesthetic including pruritis, hypotension, arrhythmia or hematoma formation were noticed in both groups.

Conclusion:
Although ultrasound transcutaneous TAP block has shown promising and effective pain relief when used as a part of conventional multimodal post-operative analgesia, yet the surgical TAP block still needs further evaluation. We concluded in our study that surgical TAP block has provided slightly better post-operative pain relief in the 1st 6 hours and also decreased opioid consumption, however, this effect was not comparable to the results achieved by transcutaneous TAP block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49066 0
Dr Mahmoud Yehia Ahmed Moussa
Address 49066 0
organization: Ain Shams Maternity University hospital
Ahmed Lotfy Elsayed Street, Abbassya square,
Cairo
post code 11566
Country 49066 0
Egypt
Phone 49066 0
+201008166432
Fax 49066 0
Email 49066 0
dr.mahmoud.mosa@gmail.com
Contact person for public queries
Name 49067 0
A/Prof Tarek Ali Raafat
Address 49067 0
organization: Ain Shams Maternity University hospital
Ahmed Lotfy Elsayed Street, Abbassya square,
Cairo
post code 11566
Country 49067 0
Egypt
Phone 49067 0
+201007779543
Fax 49067 0
Email 49067 0
dr_tarekaly@yahoo.com
Contact person for scientific queries
Name 49068 0
A/Prof Tarek Ali Raafat
Address 49068 0
organization: Ain Shams Maternity University hospital
Ahmed Lotfy Elsayed Street, Abbassya square,
Cairo
post code 11566
Country 49068 0
Egypt
Phone 49068 0
+201007779543
Fax 49068 0
Email 49068 0
dr_tarekaly@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary