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

NCT02314104 | Completed Results

• 1 other identifier: 11-02
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

Surgical procedures, Minimally invasive; Nerve block; Anesthetics, Local

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively

  A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

  one hour postoperatively

• Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively

  A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

  six hours postoperatively

• Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively

  A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

  twenty-four hours postoperatively

Secondary Outcomes (2)

• Time Until First Request for Pain Medication

  up to twenty-four hours postoperatively

• Total Narcotic Usage in Morphine Equivalents

  up to twenty-four hours postoperatively

Study Arms (3)

Treatment TAP, placebo local injection

ACTIVE COMPARATOR

Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.

Drug: ropivacaine

Placebo TAP, treatment local injection

ACTIVE COMPARATOR

Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.

Drug: ropivacaine

Treatment TAP, treatment local injection

ACTIVE COMPARATOR

Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.

Drug: ropivacaine

Interventions

ropivacaine DRUG

Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.

Also known as: Naropin

Placebo TAP, treatment local injection; Treatment TAP, placebo local injection; Treatment TAP, treatment local injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Fibromyalgia
• Chronic pelvic pain
• Relevant drug allergy
• Conversion to laparotomy
• Pregnant

Sponsors & Collaborators

• Liberman, Eric, D.O.: lead

Study Sites (1)

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Related Publications (5)

• Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

  PMID: 19020158 BACKGROUND

• El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.

  PMID: 25088860 BACKGROUND

• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

  PMID: 18020088 BACKGROUND

• Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.

  PMID: 22840413 BACKGROUND

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Eric Liberman
• Organization: St. Barnabas Medical Center

eliberma@montefiore.org

917-696-1370

Study Officials

• Eric C Liberman, D.O.

  St. Barnabas Medical Center

  PRINCIPAL INVESTIGATOR

• Thad Denehy, M.D.

  St. Barnabas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 14, 2015
• Results First Posted: April 14, 2015

Record last verified: 2015-04

Locations

US (1)