Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01075074
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

The use of pre-operative transversus abdominis plane block will reduce pain after outpatient laparoscopic gynecological surgery and improve quality of recovery.

Condition or Disease	Intervention/Treatment	Phase
Pain; Surgery	Procedure: Transversus abdominis plane block	N/A

Detailed Description

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:

1. How much pain they are experiencing 0-10

2. How and what kind of pain medications have been used since discharge.

3. If they have had any nausea

4. What kind of nausea relief medications have been used since discharge

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: The Effect of Pre Operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Outpatient Laparoscopic Gynecological Surgery: A Prospective, Randomized Blinded Study
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ropivacaine 0.05% Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side	Procedure: Transversus abdominis plane block; A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.; Other Names: TAP block
Placebo Comparator: Normal Saline Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.	Procedure: Transversus abdominis plane block; A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.; Other Names: TAP block
Active Comparator: Ropivacaine 0.25% Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side	Procedure: Transversus abdominis plane block; A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.; Other Names: TAP block

Outcome Measures

Primary Outcome Measures

1. The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery [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.

Secondary Outcome Measures

1. Pain Burden During Early Recovery From Anesthesia [Post Operative]

   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.

2. Opioid Pain Medications Consumed During the First 24 Hours Post Surgery [24 hours]

   Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge

3. Time to Hospital Discharge Readiness [24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18-64 years

• Surgery: Outpatient Gynecological laparoscopic surgery

• ASA status: I and II

• Fluent in English

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Gildasio DeOliveira, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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.
• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.
• 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.
• Lovatsis D, José 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.
• Møiniche 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.
• 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. Erratum in: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].
• 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.
• Turner GA, Chalkiadis G. Comparison of preoperative with postoperative lignocaine infiltration on postoperative analgesic requirements. Br J Anaesth. 1994 May;72(5):541-3.
• Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. Review.

• Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01075074
• Other Study ID Numbers: STU00023475
• First Posted: Feb 24, 2010
• Last Update Posted: Nov 21, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University: Pain; TAP block; Laparoscopic; Gynecologic

Study Results

Participant Flow

Recruitment Details	Recruited from Prentice Women's Hospital consecutively from 04/01/2010-02/2011

Arm/Group Title	Ropivacaine 0.05%	Normal Saline	Ropivacaine 0.25%
Arm/Group Description	Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine	Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline	Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	24	23	23
NOT COMPLETED	1	2	2

Baseline Characteristics

Arm/Group Title	Ropivacaine 0.05%	Normal Saline	Ropivacaine 0.25%	Total
Arm/Group Description	Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine	Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline	Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%	Total of all reporting groups
Overall Participants	25	25	25	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	25 100%	75 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38 (8)	38 (10)	35 (9)	37 (9)
Sex: Female, Male (Count of Participants)
Female	25 100%	25 100%	25 100%	75 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	25 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery
Description	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.
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ropivacaine 0.5%	Normal Saline	Ropivacaine 0.25%
Arm/Group Description	The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Measure Participants	24	23	23
Median (Full Range) [units on a scale]	172	157	173

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments	A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	Corrected for 6 comparisons.
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	16
	Confidence Interval	(2-Sided) 95%; 1 to 30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	17
	Confidence Interval	(2-Sided) 95%; 2 to 31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; -16 to 12
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Pain Burden During Early Recovery From Anesthesia
Description	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.
Time Frame	Post Operative

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ropivacaine 0.5%	Normal Saline	Ropivacaine 0.25%
Arm/Group Description	The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Measure Participants	24	23	23
Median (Inter-Quartile Range) [score on a scale * minutes]	210 (4)	405 (4)	210 (4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	P values is corrected for 6 comparisons
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	Corrected for 6 comparisons
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	195
	Confidence Interval	(2-Sided) 95%; 98 to 300
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	195
	Confidence Interval	(2-Sided) 95%; 98 to 278
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -105 to 83
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Opioid Pain Medications Consumed During the First 24 Hours Post Surgery
Description	Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ropivacaine 0.5%	Normal Saline	Ropivacaine 0.25%
Arm/Group Description	Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side	Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.	Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
Measure Participants	21	23	22
Mean (Full Range) [mEq of PO morphine equivalent]	40	78	39

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments	Corrected for multiple comparisons (n=6).
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	38
	Confidence Interval	(2-Sided) 95%; 8 to 50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	40
	Confidence Interval	(2-Sided) 95%; 12 to 47
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; -18 to 20
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Time to Hospital Discharge Readiness
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ropivacaine 0.5%	Normal Saline	Ropivacaine 0.25%
Arm/Group Description	The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side	The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.	The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Measure Participants	24	23	23
Median (Inter-Quartile Range) [minutes]	90	120	90

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	Corrected for multiple comparisons (n=6).
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	30
	Confidence Interval	(2-Sided) 95%; 0 to 60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	30
	Confidence Interval	(2-Sided) 95%; 0 to 60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -30 to 30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Post anesthesia care unit until discharge
Arm/Group Title	Ropivacaine 0.5%		Normal Saline		Ropivacaine 0.25%
Arm/Group Description	Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine		Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.		Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
All Cause Mortality
	Ropivacaine 0.5%		Normal Saline		Ropivacaine 0.25%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ropivacaine 0.5%		Normal Saline		Ropivacaine 0.25%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Ropivacaine 0.5%		Normal Saline		Ropivacaine 0.25%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/25 (48%)		11/25 (44%)		12/25 (48%)
Gastrointestinal disorders
Nausea	12/24 (50%)	12	11/23 (47.8%)	11	12/23 (52.2%)	12

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.