Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

• ClinicalTrials.gov Identifier: NCT01075074
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Results First Posted: April 3, 2012
• Last Update Posted: November 21, 2013
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Gildasio De Oliveira, Northwestern University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Conditions: Pain; Surgery
• Intervention: Procedure: Transversus abdominis plane block
• Enrollment: 75

Participant Flow

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

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
Reason Not Completed
Surgeon changed to open incisional case	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 Number of Baseline Participants		25	25	25	75
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	25 participants	25 participants	75 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	25 100.0%	25 100.0%	25 100.0%	75 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	25 participants	25 participants	75 participants
		38 (8)	38 (10)	35 (9)	37 (9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	25 participants	25 participants	75 participants
	Female	25 100.0%	25 100.0%	25 100.0%	75 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	25 participants	25 participants	25 participants	75 participants
		25	25	25	75

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
Overall Number of Participants Analyzed	24	23	23
Median (Full Range); Unit of Measure: units on a scale
	172; (160 to 190)	157; (148 to 169)	173; (165 to 189)

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	Corrected for 6 comparisons.
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.03
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	16
	Confidence Interval	(2-Sided) 95%; 1 to 30
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	17
	Confidence Interval	(2-Sided) 95%; 2 to 31
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.0
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; -16 to 12
	Estimation Comments	[Not Specified]

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
Overall Number of Participants Analyzed	24	23	23
Median (Inter-Quartile Range); Unit of Measure: score on a scale * minutes
	210; (90 to 345)	405; (360 to 502)	210; (135 to 365)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	P values is corrected for 6 comparisons
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	Corrected for 6 comparisons
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	195
	Confidence Interval	(2-Sided) 95%; 98 to 300
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	195
	Confidence Interval	(2-Sided) 95%; 98 to 278
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.86
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -105 to 83
	Estimation Comments	[Not Specified]

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
Overall Number of Participants Analyzed	21	23	22
Mean (Full Range); Unit of Measure: mEq of PO morphine equivalent
	40; (13 to 72)	78; (61 to 90)	39; (25 to 58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	Corrected for multiple comparisons (n=6).
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	38
	Confidence Interval	(2-Sided) 95%; 8 to 50
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	40
	Confidence Interval	(2-Sided) 95%; 12 to 47
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.95
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; -18 to 20
	Estimation Comments	[Not Specified]

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
Overall Number of Participants Analyzed	24	23	23
Median (Inter-Quartile Range); Unit of Measure: minutes
	90; (75 to 120)	120; (105 to 150)	90; (75 to 135)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.03
	Comments	Corrected for multiple comparisons (n=6).
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Normal Saline
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	30
	Confidence Interval	(2-Sided) 95%; 0 to 60
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Normal Saline, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.04
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	30
	Confidence Interval	(2-Sided) 95%; 0 to 60
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ropivacaine 0.5%, Ropivacaine 0.25%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.92
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -30 to 30
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Post anesthesia care unit until discharge
Adverse Event Reporting Description	[Not Specified]
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 (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
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 (0.00%)		0/25 (0.00%)		0/25 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ropivacaine 0.5%		Normal Saline		Ropivacaine 0.25%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/25 (48.00%)		11/25 (44.00%)		12/25 (48.00%)
Gastrointestinal disorders
Nausea † 1	12/24 (50.00%)	12	11/23 (47.83%)	11	12/23 (52.17%)	12
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (10.0)

Limitations and 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.

Results Point of Contact

• Name/Title: Gildasio De Oliveira, MD
• Organization: Northwestern University
• Phone: 312-926-8373
• EMail: g-jr@northwestern.edu

Publications:

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.

Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. 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.

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.

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.

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.

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.

Turner GA, Chalkiadis G. Comparison of preoperative with postoperative lignocaine infiltration on postoperative analgesic requirements. Br J Anaesth. 1994 May;72(5):541-3.

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].

Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.

• Responsible Party: Gildasio De Oliveira, Northwestern University
• ClinicalTrials.gov Identifier: NCT01075074
• Other Study ID Numbers: STU00023475
• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Results First Submitted: March 6, 2012
• Results First Posted: April 3, 2012
• Last Update Posted: November 21, 2013