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N/A N=220 Randomized Triple-blind Treatment

Efficacy of Transversus Abdominis Plane Block Versus Local Injection of Pain Medication

Pain, Postoperative

Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively — 4.04; 5.09; 4.4 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ropivacaine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Liberman, Eric, D.O.
Primary completion
Oct 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively
4.04; 5.09; 4.4
PRIMARY
Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively
3.53; 3.5; 3.33
PRIMARY
Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively
3.36; 3.56; 3.51
SECONDARY
Time Until First Request for Pain Medication
46; 31; 28
SECONDARY
Total Narcotic Usage in Morphine Equivalents
20.09; 23.14; 20.68

Summary

The purpose of this study is to determine if there is a better method of administering pain medication prior to minimally invasive gynecological surgery so that postoperative pain and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the use of local pain medications in minimally invasive gynecological surgery and practices vary widely among physicians, even within the same institution. The two methods of preemptive pain medication that this study will be looking at is the transversus abdominis plane (TAP) block and the local injection of pain medication at the areas of the skin incisions. TAP block is a procedure performed by a specially trained pain management anesthesiologist in which there is an injection of a local pain medication into the abdominal wall, specifically in a space where the nerves that are responsible for postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and has been found to be successful in decreasing postoperative pain in a number of procedures. The local injection of pain medications at the incision sites has also been found to be beneficial in decreasing postoperative pain. However, it is not known whether one method is superior to the other in decreasing postoperative pain or if the combination of both is best. Patients that chose to participate are randomly (by chance) assigned to one of three groups: 1) TAP block with pain medication and local injection of normal saline (water) at the incision sites 2) TAP block with normal saline and local injection of pain medication at the incision sites or 3) TAP block with pain medication and local injection of pain medication at the port sites. These procedures are performed while the patient is asleep. Patients will be asked to record their level of pain on a standardized pain scale at one hour, six hours, and twenty-four hours after the surgery. All patients are provided with standard postoperative pain medications as needed. The hypothesis is that patients receiving both TAP block and local injection of pain medication at the port sites will have less pain postoperatively and require a smaller amount of narcotics than those that receive either the TAP block or local injection of pain medication alone.

Eligibility Criteria

Inclusion Criteria

  • Female
  • Undergoing gynecological robotic and/or laparoscopic surgery
  • Overnight hospitalization expected

Exclusion Criteria

  • Fibromyalgia
  • Chronic pelvic pain
  • Relevant drug allergy
  • Conversion to laparotomy
  • Pregnant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02314104). 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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