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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaine 100 mg, USG TAP Block | Active Comparator | 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery |
|
| Placebo | Placebo Comparator | 20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction at 72 hours from surgery | Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied) | 72 hours |
| The time of recovery of bowel function at 72 hours from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierfrancesco Fusco, MD | Anesthesia and Intensive care Unit, San Salvatore Academic Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27906937 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Saline | Drug | 20 ml of saline saline by intramuscular injection, at the end of surgery |
|
|
Time (in hours) to have defacation
| 72 hours |
| The time of hospital discharge at 72 hours after surgery | Time (days after surgery) for hospital discharging | 72 hours |
| The consumption of painkillers at 72 hours after surgery | The equianalgesic dose (in mg) of morphine. | 72 hours |
| The healing of the surgical wound at 72 hours | Descriptive scale of four step: unacceptable/acceptable/excellent healing | 72 hours |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |