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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | sterile normal saline as placebo |
|
| Drug .5% Ropivacaine | Active Comparator | Instillation of 20 cc of 0.5% ropivacaine |
|
| 20 cc of 0.25% ropivacaine | Active Comparator | Instillation of 20 cc of 0.25% ropivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Total Morphine Consumption | Total 24 total morphine consumption post operative. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
Drop-out criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio DeOliveira, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16738152 | Background | 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. | |
| 17346525 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Group B (control group) will receive sterile normal saline. |
| FG001 | 20 cc of 0.5% Ropivacaine | Group A (study group) 20 cc of 0.5% ropivacaine |
| FG002 | 20 cc of 0.25% Ropivacaine | Active Comparator 2. 20 cc of 0.25% ropivacaine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Group B (control group) will receive sterile normal saline. |
| BG001 | Study Drug | Group A (study group) 20 cc of 0.5% ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Group B (control group) will receive sterile normal saline. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira, MD | Northwestern University | 312-926-8373 | g-jr@northwestern.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug .5% Ropivacaine | Drug | .5% ropivacaine 20 mls on each side of abdomen |
|
|
| 20 cc of 0.25% ropivacaine | Drug | Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine |
|
|
| 19762758 | 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. |
| 17022920 | 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. |
| 17714620 | 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. |
| 10718794 | 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. |
| 10910857 | 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. |
| 11703235 | 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. |
| 9861124 | 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. |
| 12670813 | 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. |
| 22105251 | Derived | 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. |
| BG002 | 20 cc of 0.25% Ropivacaine | Active Comparator 2. 20 cc of 0.25% ropivacaine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Active Comparator 2. 20 cc of 0.25% ropivacaine
|
|
|
| Secondary | 24 Total Morphine Consumption | Total 24 total morphine consumption post operative. | Posted | Mean | Standard Deviation | miligrams of morphine | 1 day |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Study Drug | Group A (study group) 20 cc of 0.5% ropivacaine | 0 | 25 | 0 | 25 |
| EG002 | 20 cc of 0.25% Ropivacaine | Active Comparator 2. 20 cc of 0.25% ropivacaine | 0 | 25 | 0 | 25 |
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| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| Median Difference (Net) |
| 10 |
| 2-Sided |
| 95 |
| 3 |
| 15 |
| No |
| Superiority or Other |
| Dunns test | 0.14 | Mean Difference (Net) | 5 | 2-Sided | 95 | -1 | 12 | No | Superiority or Other |