Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy

NCT01074229 | Completed Results

• 1 other identifier: STU00023440
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery. Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics. Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%. This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.

Conditions

Postoperative Pain

Keywords

Pain; Post Operative; Opioids; Laparoscopic; Surgery; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• QoR40 on the Day After Surgery

  QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.

  1 day

Secondary Outcomes (1)

• 24 Total Morphine Consumption

  1 day

Study Arms (3)

Placebo

PLACEBO COMPARATOR

sterile normal saline as placebo

Drug: Placebo

Drug .5% Ropivacaine

ACTIVE COMPARATOR

Instillation of 20 cc of 0.5% ropivacaine

Drug: Drug .5% Ropivacaine

20 cc of 0.25% ropivacaine

ACTIVE COMPARATOR

Instillation of 20 cc of 0.25% ropivacaine

Drug: 20 cc of 0.25% ropivacaine

Interventions

Placebo DRUG

placebo injection

Also known as: Sterile normal saline

Placebo

Drug .5% Ropivacaine DRUG

.5% ropivacaine 20 mls on each side of abdomen

Also known as: .5% Ropivacaine

Drug .5% Ropivacaine

20 cc of 0.25% ropivacaine DRUG

Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine

Also known as: .25% ropivacaine

20 cc of 0.25% ropivacaine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-64 years
• Surgery: Laparoscopic Hysterectomy surgery
• ASA status: I and II
• Fluent in English

You may not qualify if:

• History of allergy to local anesthetics
• History of chronic opioid use
• Pregnant patients
• BMI greater than 30
• Drop-out criteria:
• Patient or surgeon request
• Complications related to the procedure

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.

  PMID: 16738152 BACKGROUND

• Babalola EO, Bharucha AE, Schleck CD, Gebhart JB, Zinsmeister AR, Melton LJ 3rd. Decreasing utilization of hysterectomy: a population-based study in Olmsted County, Minnesota, 1965-2002. Am J Obstet Gynecol. 2007 Mar;196(3):214.e1-7. doi: 10.1016/j.ajog.2006.10.390.

  PMID: 17346525 BACKGROUND

• Lenz H, Sandvik L, Qvigstad E, Bjerkelund CE, Raeder J. A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. Anesth Analg. 2009 Oct;109(4):1279-83. doi: 10.1213/ane.0b013e3181b0f0bb.

  PMID: 19762758 BACKGROUND

• Thiel JA, Kamencic H. Assessment of costs associated with outpatient total laparoscopic hysterectom. J Obstet Gynaecol Can. 2006 Sep;28(9):794-798. doi: 10.1016/S1701-2163(16)32258-7.

  PMID: 17022920 BACKGROUND

• Lovatsis D, Jose JB, Tufman A, Drutz HP, Murphy K. Assessment of patient satisfaction with postoperative pain management after ambulatory gynaecologic laparoscopy. J Obstet Gynaecol Can. 2007 Aug;29(8):664-7. doi: 10.1016/s1701-2163(16)32552-x.

  PMID: 17714620 BACKGROUND

• Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.

  PMID: 10718794 BACKGROUND

• Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.

  PMID: 10910857 BACKGROUND

• Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.

  PMID: 11703235 BACKGROUND

• Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.

  PMID: 9861124 BACKGROUND

• Keita H, Benifla JL, Le Bouar V, Porcher R, Wachowska B, Bedairia K, Mantz J, Desmonts JM. Prophylactic ip injection of bupivacaine and/or morphine does not improve postoperative analgesia after laparoscopic gynecologic surgery. Can J Anaesth. 2003 Apr;50(4):362-7. doi: 10.1007/BF03021033.

  PMID: 12670813 BACKGROUND

• De Oliveira GS Jr, Milad MP, Fitzgerald P, Rahmani R, McCarthy RJ. Transversus abdominis plane infiltration and quality of recovery after laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1230-1237. doi: 10.1097/AOG.0b013e318236f67f.

  PMID: 22105251 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Pharmaceutical Preparations; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Ropivacaine blood levels were not obtained. Distribution of study drug unable to gauge due to general anesthesia. Study underpowered to detect a difference in opioid consumption or global QoR-40 between the ropivacaine 0.25% and 0.5% groups.

Results Point of Contact

• Title: Gildasio De Oliveira, MD
• Organization: Northwestern University

g-jr@northwestern.edu

312-926-8373

Study Officials

• Gildasio DeOliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 8, 2014
• Results First Posted: May 8, 2014

Record last verified: 2014-04

Locations

US (1)