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

• ClinicalTrials.gov Identifier: NCT02728323
• Recruitment Status: Terminated
• First Posted: April 5, 2016
• Last Update Posted: August 12, 2020
• Sponsor: Emiliano Petrucci
• Information provided by (Responsible Party): Emiliano Petrucci, San Salvatore Hospital of L'Aquila

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

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Emiliano Petrucci

Investigators

• Principal Investigator: Pierfrancesco Fusco, MD; Anesthesia and Intensive care Unit, San Salvatore Academic Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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