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The use of pre-operative transversus abdominis plane block will reduce pain after outpatient laparoscopic gynecological surgery and improve quality of recovery.
75 subjects will be randomly allocated into 3 groups, using a computer generated table of random numbers. Group A (study group) will receive a bilateral TAP block using 15 cc of 0.5% ropivacaine on each side. Group B (control group) will receive 15 cc of sterile normal saline. Group C (study group 2) will receive a bilateral TAP block using 15 cc of 0.25% ropivacaine on each side.
Subjects will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg. Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg /kg). After induction, a bilateral TAP block will be performed in both groups, under ultrasound guidance with a transportable ultrasound device (SonoSite, Bothell, WA, USA) and a linear 6-13 MHz ultrasound transducer .Once the EOAM, IOAM and TAM are visualized at the level of the anterior axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe will be prepared in a sterile manner. Then the block will be performed with a 21 G 90mm StimuQuik needle( Arrow International, Reading, PA, USA ) utilizing an "in- plane" ultrasound-guided technique by three investigators (GDO ,AP). Once the tip of the needle is placed in the space between the IOAM and TAM, and after negative aspiration of blood, 15 cc of 0.5% ropivacaine, 15 cc of 0.25% ropivacaine or sterile normal saline will be administered under direct ultrasonographic guidance. The contralateral block will be performed in the same fashion. Anesthesia will be maintained with sevoflurane titrated to maintain a bispectral index (BIS) between 40-60 , remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values , and rocuronium that will be administered at the discretion of the anesthesiologist. Upon termination of the surgery, neuromuscular blockade will be antagonized with a combination of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Subjects will also receive ketorolac 30 mg IV after discontinuation of remifentanil for postoperative pain control. Ondansetron 4 mg IV will be administered to prevent postoperative nausea and vomiting. Subjects will be assessed in the OR after extubation for their pain using a numerical rating scale and if pain greater than 4/10 they will receive hydromorphone(10 mcg /kg IV) Subjects will receive IV Hydromorphone in divided doses as needed to achieve a verbal rating score for pain <4 out of 10 In PACU.They will also receive metoclopramide (20 mg IV ) as rescue antiemetic in PACU. The primary and secondary outcomes will be assessed by an independent observer who will be blinded to group allocation (CA, AP, SA, YV, RJM and PF). A study team representative will telephone the participant at 24 hours, to complete the modified quality of recovery (QOR40) survey and ask the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 0.05% | Active Comparator | Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side |
|
| Normal Saline | Placebo Comparator | Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline. |
|
| Ropivacaine 0.25% | Active Comparator | Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus abdominis plane block | Procedure | A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region. |
| Measure | Description | Time Frame |
|---|---|---|
| The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery | The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Burden During Early Recovery From Anesthesia | Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable. | Post Operative |
| Opioid Pain Medications Consumed During the First 24 Hours Post Surgery |
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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 |
|---|---|---|---|
| 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. |
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Recruited from Prentice Women's Hospital consecutively from 04/01/2010-02/2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine 0.05% | Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine |
| FG001 | Normal Saline | Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline |
| FG002 | Ropivacaine 0.25% | Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025% |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine 0.05% | Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine |
| BG001 | Normal Saline | Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline |
| 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 | The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery | The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery. | 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure. | Posted | Median | Full Range | units on a scale | 24 hours after surgery |
|
Post anesthesia care unit until discharge
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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 | Ropivacaine 0.5% | Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
We did not obtain local anesthetic levels to compare safety profile. We were underpowered to detect a difference in the physical comfort dimension of the QOR questionnaire between the ropivacaine groups and the saline group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gildasio De Oliveira, MD | Northwestern University | 312-926-8373 | g-jr@northwestern.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge |
| 24 hours |
| Time to Hospital Discharge Readiness | Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge. | 24 hours |
| 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. |
| 19606021 | Background | Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a. |
| 8198905 | Background | Turner GA, Chalkiadis G. Comparison of preoperative with postoperative lignocaine infiltration on postoperative analgesic requirements. Br J Anaesth. 1994 May;72(5):541-3. doi: 10.1093/bja/72.5.541. |
| 16418039 | Background | O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available. |
| 18020088 | 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. |
| BG002 | Ropivacaine 0.25% | Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025% |
| 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 |
|
| OG001 | Normal Saline | The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline. |
| OG002 | Ropivacaine 0.25% | The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side |
|
|
|
| Secondary | Pain Burden During Early Recovery From Anesthesia | Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable. | 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure. | Posted | Median | Inter-Quartile Range | score on a scale * minutes | Post Operative |
|
|
|
|
| Secondary | Opioid Pain Medications Consumed During the First 24 Hours Post Surgery | Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge | 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure. | Posted | Mean | Full Range | mEq of PO morphine equivalent | 24 hours |
|
|
|
|
| Secondary | Time to Hospital Discharge Readiness | Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge. | 75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure. | Posted | Median | Inter-Quartile Range | minutes | 24 hours |
|
|
|
|
| 0 |
| 25 |
| 12 |
| 25 |
| EG001 | Normal Saline | Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline. | 0 | 25 | 11 | 25 |
| EG002 | Ropivacaine 0.25% | Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25% | 0 | 25 | 12 | 25 |
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| 0.0003 |
Corrected for 6 comparisons |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.0004 | Median Difference (Net) | 195 | 2-Sided | 95 | 98 | 300 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.0003 | Median Difference (Net) | 195 | 2-Sided | 95 | 98 | 278 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.86 | Median Difference (Net) | 0 | 2-Sided | 95 | -105 | 83 | No | Superiority or Other |
| 0.01 |
| Median Difference (Net) |
| 38 |
| 2-Sided |
| 95 |
| 8 |
| 50 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.003 | Median Difference (Net) | 40 | 2-Sided | 95 | 12 | 47 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.95 | Median Difference (Net) | 1 | 2-Sided | 95 | -18 | 20 | No | Superiority or Other |
| Median Difference (Net) |
| 30 |
| 2-Sided |
| 95 |
| 0 |
| 60 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.04 | Median Difference (Net) | 30 | 2-Sided | 95 | 0 | 60 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.92 | Median Difference (Net) | 0 | 2-Sided | 95 | -30 | 30 | No | Superiority or Other |