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

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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

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date August 12, 2020
Study Start Date  ICMJE October 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
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").
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery [ Time Frame: 72 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2018)
  • 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)
  • The time of recovery of bowel function at 72 hours from surgery [ Time Frame: 72 hours ]
    Time (in hours) to have defacation
  • The time of hospital discharge at 72 hours after surgery [ Time Frame: 72 hours ]
    Time (days after surgery) for hospital discharging
  • The consumption of painkillers at 72 hours after surgery [ Time Frame: 72 hours ]
    The equianalgesic dose (in mg) of morphine.
  • The healing of the surgical wound at 72 hours [ Time Frame: 72 hours ]
    Descriptive scale of four step: unacceptable/acceptable/excellent healing
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • Patient satisfaction (descriptive scale in four step: not at all/slightly/somewhat/very satisfied) 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 (days after surgery) at 72 hours after surgery [ Time Frame: 72 hours ]
  • The consumption of painkillers (in mg) at 72 hours after surgery [ Time Frame: 72 hours ]
  • The healing of the surgical wound (descriptive scale of four step: unacceptable/acceptable/excellent healing) at 72 hours [ Time Frame: 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
Official Title  ICMJE Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Levobupivacaine
    100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
    Other Name: Chirocaine
  • Drug: Saline
    20 ml of saline saline by intramuscular injection, at the end of surgery
    Other Name: Saline solution
Study Arms  ICMJE
  • Active Comparator: Levobupivacaine 100 mg, USG TAP Block
    100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
    Intervention: Drug: Levobupivacaine
  • Placebo Comparator: Placebo
    20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
    Intervention: Drug: Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2016)
96
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728323
Other Study ID Numbers  ICMJE 0057864/13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emiliano Petrucci, San Salvatore Hospital of L'Aquila
Study Sponsor  ICMJE Emiliano Petrucci
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierfrancesco Fusco, MD Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
PRS Account San Salvatore Hospital of L'Aquila
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP