Abdominal Wall Local Anesthesia to Maximize Postoperative Pain Control After Cesarean Delivery

Ultrasound Guided 0.25% Ropivacaine Transversus Abdominis Plane Block in Addition to Intrathecal Morphine and Multimodal Analgesia for the Management of Postoperative Pain Among Women Undergoing Cesarean Delivery.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01261637

Enrollment

Registered

2010-12-16

Start date

2009-07-31

Completion date

2011-01-31

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

cesarean, pain, transversus abdominus plane block

Brief summary

This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.

Interventions

DRUGSaline placebo

20ml saline

DRUGRopivicaine

0.25% ropivicaine (maximum 1.5mg/kg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Non-emergent CD with planned spinal anesthesia * American Society of Anesthesia physical status class I & II * Age ≥ 18 years * Term gestational age (≥ 37 weeks) * English-speaking

Exclusion criteria

* Morbid Obesity (BMI³ 45 kg/m2) * Laboring women * Emergency CD * Severe maternal cardiac disease * Subjects with significant obstetric co-morbidities * Failed spinal anesthesia * Patient enrollment in another study involving medication within 30 days of CD * Any other condition which may impair ability to cooperate with data collection * Height less than 152 cm (5'0) * Fetal anomalies or intrauterine fetal death

Design outcomes

Primary

Measure	Time frame
The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.	24 hours

Secondary

Measure	Time frame
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation	48 hours
TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake.	24 hours
Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.	6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026