Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
Primary Purpose
Pain
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levobupivacaine
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Pain
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Levobupivacaine 100 mg, USG TAP Block
Placebo
Arm Description
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
Patient satisfaction at 72 hours from surgery
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 (in hours) to have defacation
The time of hospital discharge at 72 hours after surgery
Time (days after surgery) for hospital discharging
The consumption of painkillers at 72 hours after surgery
The equianalgesic dose (in mg) of morphine.
The healing of the surgical wound at 72 hours
Descriptive scale of four step: unacceptable/acceptable/excellent healing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728323
Brief Title
Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
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 Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emiliano Petrucci
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levobupivacaine 100 mg, USG TAP Block
Arm Type
Active Comparator
Arm Description
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Other Intervention Name(s)
Chirocaine
Intervention Description
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline solution
Intervention Description
20 ml of saline saline by intramuscular injection, at the end of surgery
Primary Outcome Measure Information:
Title
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
Description
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").
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Patient satisfaction at 72 hours from surgery
Description
Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)
Time Frame
72 hours
Title
The time of recovery of bowel function at 72 hours from surgery
Description
Time (in hours) to have defacation
Time Frame
72 hours
Title
The time of hospital discharge at 72 hours after surgery
Description
Time (days after surgery) for hospital discharging
Time Frame
72 hours
Title
The consumption of painkillers at 72 hours after surgery
Description
The equianalgesic dose (in mg) of morphine.
Time Frame
72 hours
Title
The healing of the surgical wound at 72 hours
Description
Descriptive scale of four step: unacceptable/acceptable/excellent healing
Time Frame
72 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierfrancesco Fusco, MD
Organizational Affiliation
Anesthesia and Intensive care Unit, San Salvatore Academic Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27906937
Citation
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.
Results Reference
derived
Learn more about this trial
Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
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