CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
0.9% Normal Saline +3 moredrug
Likely dose
0.9% Normal Saline 15mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01170702
NCT01170702Phase 4Completed

The Postoperative Analgesic Efficacy of Varied Concentrations of Ropivacaine Used for the Transverse Abdominis Plane (TAP) Block After Cesarean Delivery

Northwestern University·interventional·Posted Jul 27, 2010·Updated Dec 8, 2021

In Brief

A Phase 4 clinical trial evaluating 0.9% Normal Saline, 0.2% Ropivacaine, and 2 other interventions for Postoperative Pain and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Since there have been no published dose-response studies investigating the effective analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia, the investigators propose a study primarily examining the effect on 24 hour post-Cesarean delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine, or 0.75% ropivacaine for TAP blocks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2010
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 15.9 years ago

Interventions

0.9% Normal Salinedrug

The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.

0.2% Ropivacainedrug

The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.

0.5% Ropivacainedrug

The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.

0.75% Ropivacainedrug

The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.