PainPhase 3NCT02728323
Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
A Phase 3 study testing Levobupivacaine and Saline in people with Pain, run by Emiliano Petrucci.
Trial summary
In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Levobupivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 3
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Caesarian Section. The Pfannenstiel incision was performed.
Who cannot join
- body mass index (BMI) >35
- allergy to local anesthetics
- skeletal and/or muscle abnormalities of the spine
- primary and/or secondary neurological diseases
- psychiatric diseases
- history of chronic pain and/or neuropathic disorders
Show all 11Show fewer
- history of drug abuse
- state of sepsis
- infection and/or tumors within the skin on the back
- primary or secondary coagulopathies
- pre-eclampsia or eclampsia.
About this study
Official title: Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial
In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method of performing this block has been matched with the obtained analgesic effect after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery
Read the detailed description
Transversus abdominis plane block (TAPB) is a regional anesthetic technique that can provide analgesia for lower abdominal surgical procedures. Previous meta-analyses and recently published clinical trials have demonstrated promising results for this technique when it is used as part of multimodal postoperative pain treatment, but no consensus exists regarding the potency of this type of anesthetic procedure for analgesia after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery. In this study, the correct execution of an USG-TAPB was verified, and then the procedure was matched with the obtained analgesic effect after a CS.
The secondary aims were to determine whether USG-TAPB could ensure a decline in postoperative requests for opiates and fewer opiate-related side effects, the return of faster bowel function, and shorter recovery time without generating critical hemodynamic changes.
- Conditions
- Pain
- Being tested
- Levobupivacaine, Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
SalineDrug
Also called Saline solution
20 ml of saline saline by intramuscular injection, at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine 100 mg, USG TAP Block | Active comparator | 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery Receives: Drug: Levobupivacaine |
| Placebo | Placebo comparator | 20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 72 hours
Secondary outcomes (5)
Patient satisfaction at 72 hours from surgery
Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)
Measured: 72 hours
The time of recovery of bowel function at 72 hours from surgery
Time (in hours) to have defacation
Measured: 72 hours
The time of hospital discharge at 72 hours after surgery
Time (days after surgery) for hospital discharging
Measured: 72 hours
The consumption of painkillers at 72 hours after surgery
The equianalgesic dose (in mg) of morphine.
Measured: 72 hours
The healing of the surgical wound at 72 hours
Descriptive scale of four step: unacceptable/acceptable/excellent healing
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionOct 2015
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emiliano Petrucci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Pierfrancesco Fusco, MD, Principal investigator, Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728323
- Sponsor's protocol ID
- 0057864/13
- Status last verified
- Aug 2020
- First submitted
- 15 Mar 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fusco P, Cofini V, Petrucci E, Scimia P, Pozone T, Paladini G, Carta G, Necozione S, Borghi B, Marinangeli F. Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome after Caesarean Section: A Randomized Controlled Clinical Trial. Pain Physician. 2016 Nov-Dec;19(8):583-591.
PubMed 27906937
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02728323
- Acronym / sponsor ID
- 0057864/13
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Emiliano PetrucciUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Apr 2016 (estimated)
- 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.
In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method of performing this block has been matched with the obtained analgesic effect after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery
Detailed description
Transversus abdominis plane block (TAPB) is a regional anesthetic technique that can provide analgesia for lower abdominal surgical procedures. Previous meta-analyses and recently published clinical trials have demonstrated promising results for this technique when it is used as part of multimodal postoperative pain treatment, but no consensus exists regarding the potency of this type of anesthetic procedure for analgesia after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery. In this study, the correct execution of an USG-TAPB was verified, and then the procedure was matched with the obtained analgesic effect after a CS.
The secondary aims were to determine whether USG-TAPB could ensure a decline in postoperative requests for opiates and fewer opiate-related side effects, the return of faster bowel function, and shorter recovery time without generating critical hemodynamic changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine 100 mg, USG TAP Block | Active comparator | Drug: Levobupivacaine100 mg of Levobupivacaine by intramuscular injection, at the end of surgery |
| Placebo | Placebo comparator | Drug: Saline20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Caesarian Section. The Pfannenstiel incision was performed.
Key exclusion criteria (11 listed)
- body mass index (BMI) >35
- allergy to local anesthetics
- skeletal and/or muscle abnormalities of the spine
- primary and/or secondary neurological diseases
- psychiatric diseases
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 |
|---|---|---|
| LevobupivacaineAlso: Chirocaine100 mg of Levobupivacaine by intramuscular injection, at the end of surgery | Drug | Levobupivacaine 100 mg, USG TAP Block |
| SalineAlso: Saline solution20 ml of saline saline by intramuscular injection, at the end of surgery | Drug | Placebo |
Primary outcome
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
Time frame: 72 hours
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
5 secondary outcomes
Patient satisfaction at 72 hours from surgery
Time frame: 72 hours
The time of recovery of bowel function at 72 hours from surgery
Time frame: 72 hours
The time of hospital discharge at 72 hours after surgery
Time frame: 72 hours
The consumption of painkillers at 72 hours after surgery
Time frame: 72 hours
The healing of the surgical wound at 72 hours
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 27906937Fusco P, Cofini V, Petrucci E, Scimia P, Pozone T, Paladini G, Carta G, Necozione S, Borghi B, Marinangeli F. Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome after Caesarean Section: A Randomized Controlled Clinical Trial. Pain Physician. 2016 Nov-Dec;19(8):583-591.
- 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.
Pierfrancesco Fusco, MD principal investigator
Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levobupivacaine and Saline in people with Pain, run by Emiliano Petrucci.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728323, which also lists 1 linked publication.
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 12 Aug 2020.