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

NCT ID: NCT01479270

Last Updated: 2018-10-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-01-31

Brief Summary

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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 hysterectomy procedures.

Detailed Description

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Conditions

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Pain, Postoperative Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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TAP Block

20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.

Group Type ACTIVE_COMPARATOR

TAP Block

Intervention Type DRUG

Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia

No Block

Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TAP Block

Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia

Intervention Type DRUG

Other Intervention Names

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Ropivacaine with Epinephrine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Robert Pollard

Clinical Fellow, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah M Kane, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

References

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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.

Reference Type DERIVED
PMID: 22840413 (View on PubMed)

Other Identifiers

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IRB10-01517

Identifier Type: -

Identifier Source: org_study_id

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