Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery

A study testing TAP Block in people with Pain, Postoperative and Anesthesia, run by MetroHealth Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient… Read more about this study

Who is it for?: Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative, Anesthesia
What is being tested?: TAP Block
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: No sites listed yet
Study dates: May 2011to Jan 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Any patient undergoing laparoscopic hysterectomy
Age ranges 18-80
Reading literacy
English speaking
Able to give informed consent

Who cannot join

History of relevant drug allergy
Chronic opioid users who may have tolerance to pain medications
Inability to understand written consent forms or give consent
Age less than 18 or over 80
Any conversion to open surgery

About this study

Official title: Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery

Conditions: Pain, Postoperative, Anesthesia
Being tested: TAP Block
Keywords: recovery, postoperative, pain, laparoscopy, hysterectomy, ropivacaine, TAP block, local anesthesia
Medical subject headings: Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAP BlockDrug
Also called Ropivacaine with Epinephrine
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia

Study groups in NCT01479270
Study group	Role	What they receive
TAP Block	Active comparator	20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance. Receives: Drug: TAP Block
No Block	No intervention	Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
Measured: Postop Day #1 or Day #2

Secondary outcomes (3)

Narcotic Use
narcotic use in mg of Morphine will be recorded
Measured: Postop Day #0 and Day #1
Visual Analog Scale (VAS) for Pain
visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
Measured: 2 and 24 hours post operative
Intraoperative Time
The total time in the operating room will be recorded to see if there is a difference between groups.
Measured: the total intraoperative time in minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jan 2012

First posted24 Nov 2011 (estimated)
Study startMay 2011
Primary completionSep 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01479270
Sponsor's protocol ID: IRB10-01517
Acronym: TAP
Status last verified: Oct 2018
First submitted: 22 Nov 2011
Last updated: 11 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.
PubMed 22840413

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery
ClinicalTrials.gov ID: NCT01479270
Acronym / sponsor ID: TAP / IRB10-01517
Conditions: Pain, Postoperative, Anesthesia
Keywords: recovery, postoperative, pain, laparoscopy, hysterectomy, ropivacaine, TAP block, local anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: MetroHealth Medical CenterUniversity, hospital or other
Study start: May 2011
Primary completion: Sep 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 24 Nov 2011 (estimated)
Results: Posted 11 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TAP Block	Active comparator	Drug: TAP Block20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
No Block	No intervention	–Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Any patient undergoing laparoscopic hysterectomy
Age ranges 18-80
Reading literacy
English speaking
Able to give informed consent

Key exclusion criteria (5 listed)

History of relevant drug allergy
Chronic opioid users who may have tolerance to pain medications
Inability to understand written consent forms or give consent
Age less than 18 or over 80
Any conversion to open surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAP BlockAlso: Ropivacaine with EpinephrineBilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia	Drug	TAP Block

Primary outcome

Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
Time frame: Postop Day #1 or Day #2
40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).

3 secondary outcomes

Narcotic Use
Time frame: Postop Day #0 and Day #1
Visual Analog Scale (VAS) for Pain
Time frame: 2 and 24 hours post operative
Intraoperative Time
Time frame: the total intraoperative time in minutes

Results and safety

Results posted to the registry on 11 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tap Block	28	28
No Block	28	28

Primary outcome: Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2

Time frame: Postop Day #1 or Day #2. Median (Full Range). Unit: units on a scale

Measure	TAP Block n = 28	No Block n = 28
Value	168.0 (125 to 195)	169.5 (116 to 194)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAP Block	0 of 28 (0%)	0 of 28 (0%)	0 of 28
No Block	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22840413Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.

Related trials for Pain, Postoperative

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah M Kane, MD principal investigator

MetroHealth Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing TAP Block in people with Pain, Postoperative and Anesthesia, run by MetroHealth Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2 (time frame: Postop Day #1 or Day #2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479270, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.