Cesarean Section ComplicationsTAPBLOCKNCT04874168
The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery:
A study testing TAP block in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- TAP block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Jun 2022
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing cesarean section under spinal anesthesia
- Aged ≥19 years and > 40 years .
- Gestational age ≥ 37 Weeks .
- Informed Consent From the Patient .
Who cannot join
- Body mass index (BMI) ≥40 kg/m2 ..
- History of recent opioid exposure .
- Hypersensitivity to any of the drugs used in the study .
- Significant cardiovascular, renal, or hepatic disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Alabbasia
ahmed G elnajar, md, 0201092672757, a7medgamal2020.ag@gmail.com
About this study
Official title: The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )
This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia
Read the detailed description
This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .
- Conditions
- Cesarean Section Complications
- Being tested
- TAP block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockDevice
Also called wound infiltration
bilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used
| Study group | Role | What they receive |
|---|---|---|
| In the TAP group (Group A ) | Active comparator | after completion of surgery, bilateral ultrasound-guided TAP block was performed .
Description of the intervention: a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used ;A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side. Receives: Device: TAP block |
| In the infiltration group (Group B ) | Active comparator | at the end of surgery, 40 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (20 mL in each of the upper and lower sides) by the obstetrician before skin closure. Receives: Device: TAP block |
| In placebo group (Group C ) | Placebo comparator | routine analgesic was administered and recorded . Receives: Device: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain at rest ;
using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis. (0 = no pain and 10 = the worst possible pain) .
Measured: From 2 hours to 24 hours postoperatively
Secondary outcomes (1)
The time to the first postoperative opioid dose
cumulative opioid consumption
Measured: at 2, 4, 6, and 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Mostafa, Ain Shams University
- Investigators
- Ahmed G Elnajar, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874168
- Sponsor's protocol ID
- tapblockvwoundInfiltration
- Acronym
- TAPBLOCK
- Status last verified
- Feb 2022
- First submitted
- 25 Apr 2021
- Last updated
- 15 Feb 2022
- 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )
- ClinicalTrials.gov ID
- NCT04874168
- Acronym / sponsor ID
- TAPBLOCK / tapblockvwoundInfiltration
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 May 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.
This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia
Detailed description
This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In the TAP group (Group A ) | Active comparator | Device: TAP blockafter completion of surgery, bilateral ultrasound-guided TAP block was performed . Description of the intervention: a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used ;A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side. |
| In the infiltration group (Group B ) | Active comparator | Device: TAP blockat the end of surgery, 40 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (20 mL in each of the upper and lower sides) by the obstetrician before skin closure. |
| In placebo group (Group C ) | Placebo comparator | Device: TAP blockroutine analgesic was administered and recorded . |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women undergoing cesarean section under spinal anesthesia
- Aged ≥19 years and > 40 years .
- Gestational age ≥ 37 Weeks .
- Informed Consent From the Patient .
Key exclusion criteria (4 listed)
- Body mass index (BMI) ≥40 kg/m2 ..
- History of recent opioid exposure .
- Hypersensitivity to any of the drugs used in the study .
- Significant cardiovascular, renal, or hepatic disease.
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 |
|---|---|---|
| TAP blockAlso: wound infiltrationbilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used | Device | In placebo group (Group C ), In the TAP group (Group A ), In the infiltration group (Group B ) |
Primary outcome
The degree of pain at rest ;
Time frame: From 2 hours to 24 hours postoperatively
using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis. (0 = no pain and 10 = the worst possible pain) .
1 secondary outcome
The time to the first postoperative opioid dose
Time frame: at 2, 4, 6, and 12 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Ahmed G Elnajar, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 4 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. 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 Ahmed Gamal Elnajar, MD (0201092672757, a7medgamal2020.ag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain at rest ; (time frame: From 2 hours to 24 hours postoperatively). 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 15 Feb 2022.