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Phase 4 N=70 Randomized Quadruple-blind Treatment

Single-shot TAP Block vs Continuous TAP Block

Postoperative Pain

Enrolled (actual)
70
Serious AEs
Results posted
May 2017
Primary outcome: Primary: Total Narcotic Usage at 48 Hours — 2.44; 2.88 mg

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
TAP-C (Device); TAP-S (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Narcotic Usage at 48 Hours
2.44; 2.88
SECONDARY
Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours
14.31; 14.40
SECONDARY
Average Pain Scores
5.31; 5.06
SECONDARY
Nausea Scores at 48 Hours
0.34; 0.34
SECONDARY
Sedation Scores at 48 Hours
0.2; 0.06

Summary

The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy

Eligibility Criteria

Inclusion criteria

  • Healthy subject undergoing laparoscopic live donor nephrectomy
  • (ASA) American Society of Anesthesiologists class 1 or 2
  • Age 18 or older, male or female
  • Desires TAP block for postoperative pain control

Exclusion criteria

  • Any contraindication for TAP block - single or continuous
  • History of substance abuse
  • Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known allergy or other contraindications to the study medications (Ropivacaine, Normal Saline, Hydromorphone, Oxycodone and Acetaminophen)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02475031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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