AnalgesiaNCT05136118
Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section
A study testing TAPB in people with Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- TAPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 25 Oct 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I and ∏
- primigravidas
- aged 21-40 years
- BMI ˂ 40
- body weight ˃ 60 kg
- singleton pregnancy
- gestational age of ≥37 weeks
- undergoing elective caesarean section under spinal anesthesia.
Who cannot join
- Parturient refusal
- parturient with a BMI > 40
- body weight < 60 kg
- ASA physical status ≥ III
- known local anesthetic (LA) allergy •contraindications to spinal anesthesia
- parturients who received analgesics in the past 24 hours
- infection at the site of the block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section
Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.
Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.
Read the detailed description
Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.
- Conditions
- Analgesia
- Being tested
- TAPB
- Keywords
- post-operative analgesia, Transversus Abdominis Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPBProcedure or surgery
TAPB will be given to parturients whether by the modified surgeon assisted approach or by the ultra-sound guided approach.
| Study group | Role | What they receive |
|---|---|---|
| Group MS | Active comparator | The modified surgeon assisted approach for TAPB Before the closure of the peritoneum, TAPB will be performed; at the level of the umbilicus 8 to 10cms from the midline bilaterally. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin slightly directed towards the ipsilateral anterior superior iliac spine. After feeling the 2 pops of the external and the internal oblique aponeurosis by the anesthesiologist, the surgeon will confirm proper needle placement by his hand inside the abdominal cavity. The LA will be injected after negative aspiration and a bleb will be palpated by the surgeon as the injection continues. The same procedure will be repeated on the other side. Receives: Procedure: TAPB |
| Group US | Active comparator | The ultra-sound guided approach for TAPB. After abdominal wall closure, the linear probe of the ultra- sound will be placed perpendicular to the skin at the mid-axillary line between the iliac crest and the costal margin; the TAP will be located between the internal oblique and the transversus abdominis muscle. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin and the 2 pops of the external and the internal oblique aponeurosis will be also felt. The LA will be injected after negative aspiration and its spread in the plane will be observed. The same procedure will be repeated on the other side. Receives: Procedure: TAPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to rescue analgesia
the time from the end of surgery until the first parturient's request for analgesia
Measured: 6 months
Secondary outcomes (5)
Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia
assessment of pain intensity at rest and on passive flexion of the hip and knee by the Numeric Pain Rating Score (NPRS) from 0 = no pain to 10 = worst pain. Assessment will be done at 2, 6, 12 and 24h postoperative.
Measured: 6 months
Number of parturients requiring postoperative analgesia
defined as pethidine needed by each parturient in the 24 hours postoperative period
Measured: 6 months
Total dose of pethidine given
defined as pethidine needed by each parturient in the 24 hours postoperative period
Measured: 6 months
Time to the parturient's first ambulation
the time to start of each parturient movement in the 24 hours postoperative period
Measured: 6 months
The analgesic satisfaction 24 hours after operation
parturients will be asked to report their satisfaction with pain management, assessed as 0 = weak, 1 = medium, 2 = good, 3 = very good, and 4 = excellent.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Nov 2021
- Primary completion30 Aug 2022
- Study completion25 Oct 2022
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.
- 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, Investigator, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136118
- Sponsor's protocol ID
- R 86/2021
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section
- ClinicalTrials.gov ID
- NCT05136118
- Acronym / sponsor ID
- R 86/2021
- Conditions
- Analgesia
- Keywords
- post-operative analgesia, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 29 Nov 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.
Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.
Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.
Detailed description
Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MS | Active comparator | Procedure: TAPBThe modified surgeon assisted approach for TAPB Before the closure of the peritoneum, TAPB will be performed; at the level of the umbilicus 8 to 10cms from the midline bilaterally. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin slightly directed towards the ipsilateral anterior superior iliac spine. After feeling the 2 pops of the external and the internal oblique aponeurosis by the anesthesiologist, the surgeon will confirm proper needle placement by his hand inside the abdominal cavity. The LA will be injected after negative aspiration and a bleb will be palpated by the surgeon as the injection continues. The same procedure will be repeated on the other side. |
| Group US | Active comparator | Procedure: TAPBThe ultra-sound guided approach for TAPB. After abdominal wall closure, the linear probe of the ultra- sound will be placed perpendicular to the skin at the mid-axillary line between the iliac crest and the costal margin; the TAP will be located between the internal oblique and the transversus abdominis muscle. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin and the 2 pops of the external and the internal oblique aponeurosis will be also felt. The LA will be injected after negative aspiration and its spread in the plane will be observed. The same procedure will be repeated on the other side. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- ASA physical status I and ∏
- primigravidas
- aged 21-40 years
- BMI ˂ 40
- body weight ˃ 60 kg
Key exclusion criteria (7 listed)
- Parturient refusal
- parturient with a BMI > 40
- body weight < 60 kg
- ASA physical status ≥ III
- known local anesthetic (LA) allergy •contraindications to spinal anesthesia
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 |
|---|---|---|
| TAPBTAPB will be given to parturients whether by the modified surgeon assisted approach or by the ultra-sound guided approach. | Procedure or surgery | Group MS, Group US |
Primary outcome
Time to rescue analgesia
Time frame: 6 months
the time from the end of surgery until the first parturient's request for analgesia
5 secondary outcomes
Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia
Time frame: 6 months
Number of parturients requiring postoperative analgesia
Time frame: 6 months
Total dose of pethidine given
Time frame: 6 months
Time to the parturient's first ambulation
Time frame: 6 months
The analgesic satisfaction 24 hours after operation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAPB in people with Analgesia, 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 28 Oct 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to rescue analgesia (time frame: 6 months). 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 28 Oct 2022.