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

NCT01479270 | Completed Results

• 1 other identifier: IRB10-01517
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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 hysterectomy procedures.

Conditions

Pain, Postoperative; Anesthesia

Keywords

recovery; postoperative; pain; laparoscopy; hysterectomy; ropivacaine; TAP block; local anesthesia

Outcome Measures

Primary Outcomes (1)

• 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).

  Postop Day #1 or Day #2

Secondary Outcomes (3)

• Narcotic Use

  Postop Day #0 and Day #1

• Visual Analog Scale (VAS) for Pain

  2 and 24 hours post operative

• Intraoperative Time

  the total intraoperative time in minutes

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

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

Drug: TAP Block

No Block

NO INTERVENTION

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

Interventions

TAP Block DRUG

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

Also known as: Ropivacaine with Epinephrine

TAP Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Related Publications (1)

• 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.

  PMID: 22840413 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ropivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Robert Pollard
• Organization: MetroHealth Medical Center

rpollard@metrohealth.org

216-778-4444

Study Officials

• Sarah M Kane, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Principal Investigator

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: October 11, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-10