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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02728323
• Other study ID #: 0057864/13
• Status: Terminated
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: August 2020
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Levobupivacaine
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
• Saline
20 ml of saline saline by intramuscular injection, at the end of surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emiliano Petrucci

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Patient satisfaction at 72 hours from surgery	Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)	72 hours
Secondary	The time of recovery of bowel function at 72 hours from surgery	Time (in hours) to have defacation	72 hours
Secondary	The time of hospital discharge at 72 hours after surgery	Time (days after surgery) for hospital discharging	72 hours
Secondary	The consumption of painkillers at 72 hours after surgery	The equianalgesic dose (in mg) of morphine.	72 hours
Secondary	The healing of the surgical wound at 72 hours	Descriptive scale of four step: unacceptable/acceptable/excellent healing	72 hours