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Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728323
Recruitment Status : Terminated (Terminated)
First Posted : April 5, 2016
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Brief 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. 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

Condition or disease Intervention/treatment Phase
Pain Drug: Levobupivacaine Drug: Saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Levobupivacaine 100 mg, USG TAP Block
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
Drug: Levobupivacaine
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
Other Name: Chirocaine

Placebo Comparator: Placebo
20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
Drug: Saline
20 ml of saline saline by intramuscular injection, at the end of surgery
Other Name: Saline solution




Primary Outcome Measures :
  1. 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").


Secondary Outcome Measures :
  1. Patient satisfaction at 72 hours from surgery [ Time Frame: 72 hours ]
    Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)

  2. The time of recovery of bowel function at 72 hours from surgery [ Time Frame: 72 hours ]
    Time (in hours) to have defacation

  3. The time of hospital discharge at 72 hours after surgery [ Time Frame: 72 hours ]
    Time (days after surgery) for hospital discharging

  4. The consumption of painkillers at 72 hours after surgery [ Time Frame: 72 hours ]
    The equianalgesic dose (in mg) of morphine.

  5. The healing of the surgical wound at 72 hours [ Time Frame: 72 hours ]
    Descriptive scale of four step: unacceptable/acceptable/excellent healing



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Caesarian Section. The Pfannenstiel incision was performed.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728323


Sponsors and Collaborators
Emiliano Petrucci
Investigators
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Principal Investigator: Pierfrancesco Fusco, MD Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emiliano Petrucci, Anesthesist, San Salvatore Hospital of L'Aquila
ClinicalTrials.gov Identifier: NCT02728323    
Other Study ID Numbers: 0057864/13
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents