AnalgesiaTAPNCT04809532
Trans Abdominis Plane (TAP) Block in Patients With Cesarean Section
A study testing Transverse abdominis plane (TAP) block, Bupivacain and Tramadol in people with Analgesia and Cesarean Section Complications, run by Armed Forces Hospital, Pakistan at 2 sites in Pakistan.
Trial summary
Objective: To compare Trans Abdominis Plane block in providing post cesarean analgesia with control group, in terms of mean postoperative use of Opioids. Study design: Randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Cesarean Section Complications
- What is being tested?
- Transverse abdominis plane (TAP) block, Bupivacain and Tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Feb 2021to 30 Apr 2021
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20 and 45 years
- Elective cesarean
- Fit to undergo surgery under spinal anesthesia
Who cannot join
- Patients who will have
- Any contraindication to spinal anesthesia
- ASA class III and IV
- Known Allergic to local anesthetic
- Eclampsia
- Placenta accreta/percretra
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Madiha Ahmed
Islamabad, 45710
Madiha Ahmed, +923345366225, madiha940@yahoo.com
- Recruiting
Department of Pediatrics
Rawalpindi, Punjab Province, 68000
arshad khushdil, FCPS, 03463300030, drarshad104589@yahoo.com
About this study
Official title: Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Cesarean Section: a Randomized Study.
Objective: To compare Trans Abdominis Plane block in providing post cesarean analgesia with control group, in terms of mean postoperative use of Opioids.
Study design: Randomized controlled trial. Place and duration Department of Anesthesiology, Combined Military Hospital, Sargodha, 25th February 2021 to 25th April 2021.
Materials and methods: A total of 60 female patients, who are planned to undergo elective c section and aged between 20-45 will be selected randomly and divided into two groups ( A and B) with 30pts each group. In Group A, at the end of surgery, TAP block will be given with 20ml of 0.25%bupvicaine via ultrasound guided sub-costal approach on both sides of midline. Time of TAP block will be recorded as time 0. Our outcomes will be: mean postoperative consumption of opioids and VAS score within 24hrs of surgery. Independent t test will be used to compare group A and B in terms of mean usage of tramadol within 24hrs of surgery. P value <0.05 will be considered statistically significant.
Read the detailed description
Analgesic efficacy of trans abdominis plane block in women undergoing Cesarean section: a randomized controlled trial.
Introduction:
Cesarean section is considered as one of the most commonly performed surgery worldwide. Based on the data from 121 countries, the trend analysis showed that between 1990 and 2014, the global average CS rate increased 12.4% (from 6.7% to 19.1%) with an average annual rate of increase of 4.4%.Its incidence in 2010 and 2013 was 41.9% and 48% respectively which was contrary to the rate of C/S recommended by the World Health Organization as fifteen percent for year 2014 .Just like all other major abdominal surgeries, c section comes with severe postoperative pain ,which if not managed properly can not only leads to prolonged immobility and its associated adverse effects but can also affect mother-baby bonding, care of baby, breast feeding and may lead to chronic pain and post-partum depression Multiple modalities are available for managing this post cesarean pain. Mostly systemic opioids are used but they are often associated with a number of undesirable side effects such as nausea, vomiting, pruritus, constipation, and respiratory depression,sedation.Other than opoids, systemic NSAIDS such as ketorolac, acetoaminophen are also used but alone they may be insufficient to treat post cesarean pain. Other analgesic options currently being used include local anesthetic techniques (local anesthetic infiltration, neuraxial blocks) acetaminophen , cyclooxygenase-2-specific inhibitors as well as analgesic adjuncts such as steroids, ketamine and α-2 agonists such as clonidine.
Neruoaxial anesthesia such as lumbar or thoracic epidurals are also used but because of constant and strict monitoring ,they are not considered economical for patients as well as for hospitals. With recent advancements in regional anesthesia, some regional blocks are now being utilized for postoperative pain relief in c sections such as TAP blocks but their use is still limited because of nonavailability of sufficient data.
Transversus abdominis plane (TAP) block provides analgesia by blocking nerves in anterior abdominal wall through introduction of a long-acting local anesthetic solution between the internal oblique and transversus abdominis muscles. Its use in c section is still limited ,but is considerd to be increased in future as is now been shown by several studies .
One of these studies is done by Uma Srivastava and collegues which showed that cumulative tramadol usage during first 24 h after surgery was significantly reduced in women given TAP block in comparison to control group C (75 ± 22 vs. 168 ± 45 mg in groups B and C, respectively, P < 0.0001.
As no local study is available and in the light of above mentioned studies, we proposed that with bilateral TAP block after c section you can provide better analgesia and improve patient's quality of life in postoperative period by reducing opoid usage and its associated side effects .
OBJECTIVE:
To compare TAP block in providing post cesarean analgesia with control group, in terms of mean reduction in postoperative use of opoids.
OPERATIONAL DEFINITIONS:
TAP block: injection of 20ml 0.25% bupvicaine given between internal oblique and transversus abdominis muscle on both sides of midline with no intervention in control group.
VAS (visual analogue score) : VAS , a linear scale that identifies the pain by the self-report of patient, and it is considered as gold standard for evaluation of pain in conscious patients 7. VAS >4 trigger for inj tramadol 1mg/kg i/v.
Analgesic consumption:- postoperative consumption of injection tramadol will be measured within 24hrs after surgery .
HYPOTHESIS:
TAP block is a safe and effective option to control postoperative analgesia after c section by reducing postoperative consumption of opioids.
MATERIALS AND METHODS:
Study design: Randomized control trial Sampling technique: Consecutive non-probability sampling Sample size: Using the study by Uma Srivastava at el, the results of which showed efficacy of TAP block in terms of cumulative tramadol usage during first 24 h after surgery in study group vs control group C as (75 ± 22 vs. 168 ± 45 mg in groups B and C ) and with the help of WHO sample size calculator, following calculations were made Level of significance: 5% Confidence interval: 95% Power of test: 80% Sample size=n= 6 patients in each group As sample size is very small, minimum 30 pts in each group will be used Group A: TAP block will be given Group B: no TAP block will be given Setting: Anesthesia department, Combined Military Hospital, Sargodha ,Pakistan. Duration: After approval from ethical committee Source: Admitted patient Patients will be allocated to two groups A or B, using lottery method. All patients will be assessed on day of surgery and written informed consent will be taken after explaining all the risks and benefits to patient.
On day of surgery, patients will be prepared for surgery and spinal anesthesia as per institutional protocols. Every patient will be given 1.5ml of 0.75% bupivacaine intrathecally to provide anesthesia for c section by consultant anesthetist. During surgery no drug other than oxytocin and anti-emetic (if required) will be given. In group A, at the end of surgery, TAP block will be given via ultrasound guided subcostal approach on both sides of midline. After strict monitoring for next 15-20mins,pt will be shifted to PACU. Time of TAP block will be recorded as time 0.
In ward , all patients will be given analgesia as per departmental protocol (injection ketorolac 30mg i/v TDS).In postoperative period intensity of pain and opioid consumption within 24hrs of surgery will be recorded. Performa till the application of TAP block will be filled by treating anesthetist, whereas remaining will be filled by trainee anesthesia.
After collecting all data, data would be entered and analyzed using SPSS Version 16.
Descriptive statistics will be used to calculate quantitative and qualitative variables. Mean and SD will be calculated for quantitative variables i.e. age weight, intensity of pain, dosage of opioids. Frequency and percentage will be calculated for qualitative variables i.e. gender. P value <0.05 will be considered statistically significant. All results would be presented as frequency tables. Effect modifiers like weight and age will be controlled by stratification and post stratification independent sample t test will be used.
Independent t test will be used to compare group A and B in terms of mean usage of tramadol within 24hrs of surgery.
- Conditions
- Analgesia, Cesarean Section Complications
- Being tested
- Transverse abdominis plane (TAP) block, Bupivacain, Tramadol
- Keywords
- Transverse abdominis plane block, cesarean section, postoperative use of opioids
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse abdominis plane (TAP) blockProcedure or surgery
Ultrasound guide bilateral TAP block at end of cesarean section
BupivacainDrug
20ml 0.25% bupvicaine
TramadolDrug
intravenous tramadol
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Transverse abdominis plane (TAP ) block via 20ml 0.25% bupvicaine on both sides of midline will be given at end of surgery Receives: Procedure: Transverse abdominis plane (TAP) block; Drug: Bupivacain; Drug: Tramadol |
| Group B | No intervention | At the end of surgery, no additional intervention will be done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative consumption of opioids
questionnaire will be filled 24hours after the surgery by trainee anesthesia and he/she will document the total consumption of intravenous tramadol after surgery
Measured: 24hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start25 Feb 2021
- Primary completion25 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, arshad khushdil, Armed Forces Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809532
- Sponsor's protocol ID
- 1506/ERC/Training
- Acronym
- TAP
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Cesarean Section: a Randomized Study.
- ClinicalTrials.gov ID
- NCT04809532
- Acronym / sponsor ID
- TAP / 1506/ERC/Training
- Conditions
- Analgesia, Cesarean Section Complications
- Keywords
- Transverse abdominis plane block, cesarean section, postoperative use of opioids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Armed Forces Hospital, PakistanUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 25 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 22 Mar 2021 (actual)
- 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.
Objective: To compare Trans Abdominis Plane block in providing post cesarean analgesia with control group, in terms of mean postoperative use of Opioids.
Study design: Randomized controlled trial. Place and duration Department of Anesthesiology, Combined Military Hospital, Sargodha, 25th February 2021 to 25th April 2021.
Materials and methods: A total of 60 female patients, who are planned to undergo elective c section and aged between 20-45 will be selected randomly and divided into two groups ( A and B) with 30pts each group. In Group A, at the end of surgery, TAP block will be given with 20ml of 0.25%bupvicaine via ultrasound guided sub-costal approach on both sides of midline. Time of TAP block will be recorded as time 0. Our outcomes will be: mean postoperative consumption of opioids and VAS score within 24hrs of surgery. Independent t test will be used to compare group A and B in terms of mean usage of tramadol within 24hrs of surgery. P value <0.05 will be considered statistically significant.
Detailed description
Analgesic efficacy of trans abdominis plane block in women undergoing Cesarean section: a randomized controlled trial.
Introduction:
Cesarean section is considered as one of the most commonly performed surgery worldwide. Based on the data from 121 countries, the trend analysis showed that between 1990 and 2014, the global average CS rate increased 12.4% (from 6.7% to 19.1%) with an average annual rate of increase of 4.4%.Its incidence in 2010 and 2013 was 41.9% and 48% respectively which was contrary to the rate of C/S recommended by the World Health Organization as fifteen percent for year 2014 .Just like all other major abdominal surgeries, c section comes with severe postoperative pain ,which if not managed properly can not only leads to prolonged immobility and its associated adverse effects but can also affect mother-baby bonding, care of baby, breast feeding and may lead to chronic pain and post-partum depression Multiple modalities are available for managing this post cesarean pain. Mostly systemic opioids are used but they are often associated with a number of undesirable side effects such as nausea, vomiting, pruritus, constipation, and respiratory depression,sedation.Other than opoids, systemic NSAIDS such as ketorolac, acetoaminophen are also used but alone they may be insufficient to treat post cesarean pain. Other analgesic options currently being used include local anesthetic techniques (local anesthetic infiltration, neuraxial blocks) acetaminophen , cyclooxygenase-2-specific inhibitors as well as analgesic adjuncts such as steroids, ketamine and α-2 agonists such as clonidine.
Neruoaxial anesthesia such as lumbar or thoracic epidurals are also used but because of constant and strict monitoring ,they are not considered economical for patients as well as for hospitals. With recent advancements in regional anesthesia, some regional blocks are now being utilized for postoperative pain relief in c sections such as TAP blocks but their use is still limited because of nonavailability of sufficient data.
Transversus abdominis plane (TAP) block provides analgesia by blocking nerves in anterior abdominal wall through introduction of a long-acting local anesthetic solution between the internal oblique and transversus abdominis muscles. Its use in c section is still limited ,but is considerd to be increased in future as is now been shown by several studies .
One of these studies is done by Uma Srivastava and collegues which showed that cumulative tramadol usage during first 24 h after surgery was significantly reduced in women given TAP block in comparison to control group C (75 ± 22 vs. 168 ± 45 mg in groups B and C, respectively, P < 0.0001.
As no local study is available and in the light of above mentioned studies, we proposed that with bilateral TAP block after c section you can provide better analgesia and improve patient's quality of life in postoperative period by reducing opoid usage and its associated side effects .
OBJECTIVE:
To compare TAP block in providing post cesarean analgesia with control group, in terms of mean reduction in postoperative use of opoids.
OPERATIONAL DEFINITIONS:
TAP block: injection of 20ml 0.25% bupvicaine given between internal oblique and transversus abdominis muscle on both sides of midline with no intervention in control group.
VAS (visual analogue score) : VAS , a linear scale that identifies the pain by the self-report of patient, and it is considered as gold standard for evaluation of pain in conscious patients 7. VAS >4 trigger for inj tramadol 1mg/kg i/v.
Analgesic consumption:- postoperative consumption of injection tramadol will be measured within 24hrs after surgery .
HYPOTHESIS:
TAP block is a safe and effective option to control postoperative analgesia after c section by reducing postoperative consumption of opioids.
MATERIALS AND METHODS:
Study design: Randomized control trial Sampling technique: Consecutive non-probability sampling Sample size: Using the study by Uma Srivastava at el, the results of which showed efficacy of TAP block in terms of cumulative tramadol usage during first 24 h after surgery in study group vs control group C as (75 ± 22 vs. 168 ± 45 mg in groups B and C ) and with the help of WHO sample size calculator, following calculations were made Level of significance: 5% Confidence interval: 95% Power of test: 80% Sample size=n= 6 patients in each group As sample size is very small, minimum 30 pts in each group will be used Group A: TAP block will be given Group B: no TAP block will be given Setting: Anesthesia department, Combined Military Hospital, Sargodha ,Pakistan. Duration: After approval from ethical committee Source: Admitted patient Patients will be allocated to two groups A or B, using lottery method. All patients will be assessed on day of surgery and written informed consent will be taken after explaining all the risks and benefits to patient.
On day of surgery, patients will be prepared for surgery and spinal anesthesia as per institutional protocols. Every patient will be given 1.5ml of 0.75% bupivacaine intrathecally to provide anesthesia for c section by consultant anesthetist. During surgery no drug other than oxytocin and anti-emetic (if required) will be given. In group A, at the end of surgery, TAP block will be given via ultrasound guided subcostal approach on both sides of midline. After strict monitoring for next 15-20mins,pt will be shifted to PACU. Time of TAP block will be recorded as time 0.
In ward , all patients will be given analgesia as per departmental protocol (injection ketorolac 30mg i/v TDS).In postoperative period intensity of pain and opioid consumption within 24hrs of surgery will be recorded. Performa till the application of TAP block will be filled by treating anesthetist, whereas remaining will be filled by trainee anesthesia.
After collecting all data, data would be entered and analyzed using SPSS Version 16.
Descriptive statistics will be used to calculate quantitative and qualitative variables. Mean and SD will be calculated for quantitative variables i.e. age weight, intensity of pain, dosage of opioids. Frequency and percentage will be calculated for qualitative variables i.e. gender. P value <0.05 will be considered statistically significant. All results would be presented as frequency tables. Effect modifiers like weight and age will be controlled by stratification and post stratification independent sample t test will be used.
Independent t test will be used to compare group A and B in terms of mean usage of tramadol within 24hrs of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Transverse abdominis plane (TAP) block, Drug: Bupivacain, Drug: TramadolTransverse abdominis plane (TAP ) block via 20ml 0.25% bupvicaine on both sides of midline will be given at end of surgery |
| Group B | No intervention | –At the end of surgery, no additional intervention will be done. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 20 and 45 years
- Elective cesarean
- Fit to undergo surgery under spinal anesthesia
Key exclusion criteria (6 listed)
- Patients who will have
- Any contraindication to spinal anesthesia
- ASA class III and IV
- Known Allergic to local anesthetic
- Eclampsia
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 |
|---|---|---|
| Transverse abdominis plane (TAP) blockUltrasound guide bilateral TAP block at end of cesarean section | Procedure or surgery | Group A |
| Bupivacain20ml 0.25% bupvicaine | Drug | Group A |
| Tramadolintravenous tramadol | Drug | Group A |
Primary outcome
postoperative consumption of opioids
Time frame: 24hours after surgery
questionnaire will be filled 24hours after the surgery by trainee anesthesia and he/she will document the total consumption of intravenous tramadol after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse abdominis plane (TAP) block, Bupivacain and Tramadol in people with Analgesia and Cesarean Section Complications, run by Armed Forces Hospital, Pakistan at 2 sites in Pakistan.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arshad Khushdil, FCPS (+92 3463300030, drarshad104589@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative consumption of opioids (time frame: 24hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2021.