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Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01075074
Enrollment
75
Registered
2010-02-24
Start date
2010-08-31
Completion date
2011-03-31
Last updated
2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Surgery

Keywords

Pain, TAP block, Laparoscopic, Gynecologic

Brief summary

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

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

Interventions

PROCEDURETransversus 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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery24 hours after surgeryThe 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

MeasureTime frameDescription
Pain Burden During Early Recovery From AnesthesiaPost OperativeArea 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.
Opioid Pain Medications Consumed During the First 24 Hours Post Surgery24 hoursOpioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge
Time to Hospital Discharge Readiness24 hoursElapsed 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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Ropivacaine 0.05%
Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
25
Normal Saline
Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
25
Ropivacaine 0.25%
Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
25
Total75

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudySurgeon changed to open incisional case122

Baseline characteristics

CharacteristicNormal SalineRopivacaine 0.25%Ropivacaine 0.05%Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
25 Participants25 Participants25 Participants75 Participants
Age Continuous38 years
STANDARD_DEVIATION 10
35 years
STANDARD_DEVIATION 9
38 years
STANDARD_DEVIATION 8
37 years
STANDARD_DEVIATION 9
Region of Enrollment
United States
25 participants25 participants25 participants75 participants
Sex: Female, Male
Female
25 Participants25 Participants25 Participants75 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
12 / 2511 / 2512 / 25
serious
Total, serious adverse events
0 / 250 / 250 / 25

Outcome results

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.

Time frame: 24 hours after surgery

Population: 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.

ArmMeasureValue (MEDIAN)
Ropivacaine 0.5%The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery172 units on a scale
Normal SalineThe Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery157 units on a scale
Ropivacaine 0.25%The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery173 units on a scale
Comparison: 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.p-value: 0.006Kruskal-Wallis
p-value: 0.0395% CI: [1, 30]Wilcoxon (Mann-Whitney)
p-value: 0.0195% CI: [2, 31]Wilcoxon (Mann-Whitney)
p-value: 195% CI: [-16, 12]Wilcoxon (Mann-Whitney)
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

Time frame: 24 hours

Population: 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.

ArmMeasureValue (MEAN)
Ropivacaine 0.5%Opioid Pain Medications Consumed During the First 24 Hours Post Surgery40 mEq of PO morphine equivalent
Normal SalineOpioid Pain Medications Consumed During the First 24 Hours Post Surgery78 mEq of PO morphine equivalent
Ropivacaine 0.25%Opioid Pain Medications Consumed During the First 24 Hours Post Surgery39 mEq of PO morphine equivalent
p-value: 0.0005Kruskal-Wallis
p-value: 0.0195% CI: [8, 50]Wilcoxon (Mann-Whitney)
p-value: 0.00395% CI: [12, 47]Wilcoxon (Mann-Whitney)
p-value: 0.9595% CI: [-18, 20]Wilcoxon (Mann-Whitney)
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.

Time frame: Post Operative

Population: 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.

ArmMeasureValue (MEDIAN)Dispersion
Ropivacaine 0.5%Pain Burden During Early Recovery From Anesthesia210 score on a scale * minutesInter-Quartile Range 4
Normal SalinePain Burden During Early Recovery From Anesthesia405 score on a scale * minutesInter-Quartile Range 4
Ropivacaine 0.25%Pain Burden During Early Recovery From Anesthesia210 score on a scale * minutesInter-Quartile Range 4
p-value: 0.0003Kruskal-Wallis
p-value: 0.0003Kruskal-Wallis
p-value: 0.000495% CI: [98, 300]Wilcoxon (Mann-Whitney)
p-value: 0.000395% CI: [98, 278]Wilcoxon (Mann-Whitney)
p-value: 0.8695% CI: [-105, 83]Wilcoxon (Mann-Whitney)
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.

Time frame: 24 hours

Population: 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.

ArmMeasureValue (MEDIAN)
Ropivacaine 0.5%Time to Hospital Discharge Readiness90 minutes
Normal SalineTime to Hospital Discharge Readiness120 minutes
Ropivacaine 0.25%Time to Hospital Discharge Readiness90 minutes
p-value: 0.03Kruskal-Wallis
p-value: 0.0195% CI: [0, 60]Wilcoxon (Mann-Whitney)
p-value: 0.0495% CI: [0, 60]Wilcoxon (Mann-Whitney)
p-value: 0.9295% CI: [-30, 30]Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026