- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03236324
Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery
Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Caesarean delivery (CD) is one of the most commonly performed surgical procedures with an estimated annual frequency of 27% in Alberta between 2007-2011. Poorly controlled postsurgical pain is associated with an increase in morbidity. Untreated or undertreated pain can lead to respiratory infections secondary to splinting and shallow breathing. Excessive pain also reduces and delays ambulation, which can lead to both an increase in the incidence of deep vein thrombosis (DVT) and delay recovery and readiness for discharge. Poorly controlled pain may also lead to the development of chronic postsurgical pain. The optimal form of postoperative analgesia following CD is not known. Most postoperative analgesic protocols for CD, despite being multimodal in nature, rely heavily on opioid medications both orally and intrathecally for analgesia. These medications, however, are not without serious side effects such as nausea, vomiting, sedation, addiction or dependence, and respiratory depression as well as expression in breast milk which may put infants at risk of side effects as well. Thus, an effective alternative analgesic modality analgesia in these patients which produces both improved pain control and reduced side effects is desired. The TFP block represents a promising alternative, which may fulfill this role in complementing multimodal analgesia for patients undergoing CD and reducing opioid administration.
This project aims to elucidate information regarding alternative interventions for postoperative analgesia following CD. While the most common analgesic regimen of intrathecal and oral opioids, acetaminophen, and NSAIDS for postoperative analgesia is effective, it is not appropriate for all patients. For those who cannot receive intrathecal opioids (e.g. those with allergies to opioid medications, or those who are undergoing CD under general anesthetic), alternative analgesic modalities are important to provide adequate multimodal analgesia and minimize side effects of each of the analgesic medications. Additionally, this aforementioned common analgesic pathway may itself be further optimized through the addition of new analgesic techniques. The Transversalis Fascia Plane (TFP) block is a nerve block, which could potentially target nerves responsible for transmitting pain following CD, and represents a promising novel analgesic modality.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Leyla Baghirzada, MD, FRCPC
- Phone Number: 403-399-6715
- Email: Leyla.Baghirzada@albertahealthservices.ca
Study Contact Backup
- Name: Ryan Endersby, MD, FRCPC
- Phone Number: 403-956-3883
- Email: Ryan.Endersby@albertahealthservices.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3M 1M4
- South Health Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- elective Cesarean delivery with spinal anesthesia at South Health Campus
- term gestation with a singleton pregnancy
- American Society of Anesthesiologists' (ASA) physical status Class 1-3
Exclusion Criteria:
- language barrier
- body mass index (BMI) > 40 kg/m2
- multiple gestations
- chronic pain
- opioid use
- substance abuse
- allergies to study medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: TFP block with saline
Placebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot
|
Transversalis fascia plane (TFP) block, ultrasound-guided
20 mL 0.9% saline administered on each side as bilateral TFP blocks
|
Experimental: TFP block with local anesthetic
Experimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot
|
Transversalis fascia plane (TFP) block, ultrasound-guided
20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption
Time Frame: 24 hours
|
24-hour postoperative opioid consumption presented in morphine equivalents
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric rating scale pain scores
Time Frame: up to 48 hours
|
Pain scores to be assessed at rest and movement 6, 12, 18, 24 and 48 hours post-Cesarean delivery
|
up to 48 hours
|
Time to first analgesia
Time Frame: 48 hours
|
Time to request of first analgesia after Cesarean delivery
|
48 hours
|
Opioid side effects
Time Frame: 48 hours
|
Evaluate incidence of nausea, vomiting, pruritus, sedation after Cesarean delivery
|
48 hours
|
Patient satisfaction
Time Frame: 48 hours
|
Evaluate patient satisfaction of postoperative pain relief at time of discharge
|
48 hours
|
Quality of recovery scores
Time Frame: up to 48 hours
|
Quality of recovery (QoR-15) scores acquired preoperatively, 24 hour and 48 hours after Cesarean delivery
|
up to 48 hours
|
Post-discharge numeric rating pain scale scores
Time Frame: up to 60 days
|
Evaluate pain scores at 30 days and 60 days after Cesarean delivery
|
up to 60 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Bupivacaine
- Epinephrine
Other Study ID Numbers
- REB15-2238
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cesarean Delivery
-
Charite University, Berlin, GermanyCompletedCesarean Section Complications | Cesarean Delivery Affecting Newborn | Cesarean Delivery Affecting FetusGermany
-
Rambam Health Care CampusRecruitingCesarean Delivery Affecting Fetus | Delivery ComplicationIsrael
-
Assiut UniversityMinistry of Health, KuwaitNot yet recruiting
-
Assiut UniversityUnknown
-
Pujic BorislavaUnknownCesarean DeliverySerbia
-
Columbia UniversityCompletedCesarean DeliveryUnited States
-
S. Anna HospitalUnknownCesarean DeliveryItaly
-
University of British ColumbiaCompletedCesarean DeliveryCanada
-
Stanford UniversityCompleted
-
National Taiwan University HospitalCompleted
Clinical Trials on ultrasound-guided nerve block
-
Theodor Bilharz Research InstituteCairo UniversityCompletedHepatic Impairment | Laparoscopic Cholecystectomy | Ultrasound TherapyEgypt
-
Zachary BinderMedical University of South Carolina; University of California, San Diego; Yale... and other collaboratorsRecruitingFemur FractureUnited States, Australia
-
Hospital San Carlos, MadridNot yet recruitingHip Fractures | Pain, Acute | Ultrasound Therapy; Complications
-
Alexandria UniversityRecruiting
-
Alexandria UniversityCompleted
-
Ain Shams UniversityCompleted
-
St. Luke's-Roosevelt Hospital CenterCompletedFall Risk | Quadriceps Muscle Weakness | Adductor Muscle WeaknessUnited States
-
Jessa HospitalCompletedAnesthesia, Local | SurgeryBelgium
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedInguinal Hernia | Post Operative Pain | Quadratus Lumborum Nerve BlockTurkey
-
Huazhong University of Science and TechnologyCompletedKnee Arthroscopy SurgeryChina