NCT01596660

Brief Summary

The ambulatory management after laparoscopic hysterectomy is a reality in our service, where 90% of hysterectomies are laparoscopically done and 80% of these are managed on an ambulatory basis with shorter hospital stay ;less than 12 hours. (OALOS 9.41 + / - (1.79) range from 5 to 12 hours and POLE 5.38 + / - (1.8) range from 2 to 9 hours) So far the immediate analgesic management has been made systemically, and the satisfaction reported by patients was high, even though some patients require longer stay in recovery and need higher doses of analgesics before their discharge criteria, allowing an optimal ambulatory management. There are several treatment options that theoretically could be used but the results have been variable and have failed to demonstrate the expected benefit. The Transversus Abdominis Plane Block consists in the deposition of local anesthetic in the plane between the internal oblique and transverse abdominal, looking to infiltrate the spinal nerves at this level, so the innervation to the skin, muscles and the parietal peritoneum will be interrupted. The TAP Block was first described in 2001 , based on anatomy marks techniques of the peripheral nerves and was developed and evaluated later by McDonnell et al.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
Last Updated

May 11, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

April 30, 2012

Last Update Submit

May 9, 2012

Conditions

Block

Keywords

Tap blocklaparoscopic hysterectomypain

Outcome Measures

Primary Outcomes (1)

  • Pain

    The instrument used to assess pain intensity is a straight line marked with numbers 1 to 10, with 1 meaning absence of pain and 10 the worst pain imaginable. The patient marks a point on the line that matches the pain she feels.

    24 hours

Study Arms (2)

Bupivacaina

EXPERIMENTAL

20 cc of bupivacaine 0.5% in 20 cc de saline solution and it is infiltrated 20 cc each side.

Drug: Bupivacaina 0.5%

saline solution

PLACEBO COMPARATOR

20 cc of saline solution 0.9% to infiltrate each side.

Drug: placebo comparator

Interventions

Bupivacaina 0.5%DRUG

Bupivacaina 0.5% 20cc

Also known as: Bupivacaine
Bupivacaina
placebo comparatorDRUG

20 cc of saline solution 0.9%, to infiltrate each side.

Also known as: Saline solution
saline solution

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients scheduled for laparoscopic hysterectomy for benign causes.
  • ASA 1 and 2
  • Patients without contraindications to the administration of local anesthetics
  • Patients without contraindications to NSAIDs or acetaminophen.
  • Patients with no simultaneous intervention (only laparoscopic hysterectomy)
  • Patients living in the metropolitan area, with telephone line, can be contacted by telephone in the first 72 hours by calling 24, 48 and 72 hours, conducted by researchers at the number previously reported by the patient.
  • An adequate level of understanding, ie patients who are able to communicate by telephone and understand a numerical scale.
  • Who agree to participate in the work.

You may not qualify if:

  • Patients who should undergo a change in the standard anesthetic technique.
  • Patients who are hospitalized after total laparoscopic hysterectomy.
  • Patients with a body mass index above 30.
  • Laparoscopic hysterectomy with a longer duration to 120 minutes.
  • Patients who do not they can be reached by phone at pre-set times.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CES

Medellín, Antioquia, Colombia

RECRUITING

Related Publications (15)

  • Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

    PMID: 11576144BACKGROUND

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.

    PMID: 17507163BACKGROUND

  • Lenz H, Sandvik L, Qvigstad E, Bjerkelund CE, Raeder J. A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. Anesth Analg. 2009 Oct;109(4):1279-83. doi: 10.1213/ane.0b013e3181b0f0bb.

    PMID: 19762758BACKGROUND

  • Scharine JD. Bilateral transversus abdominis plane nerve blocks for analgesia following cesarean delivery: report of 2 cases. AANA J. 2009 Apr;77(2):98-102.

    PMID: 19388503BACKGROUND

  • Malhotra N, Chanana C, Roy KK, Kumar S, Rewari V, Sharma JB. To compare the efficacy of two doses of intraperitoneal bupivacaine for pain relief after operative laparoscopy in gynecology. Arch Gynecol Obstet. 2007 Oct;276(4):323-6. doi: 10.1007/s00404-007-0337-1. Epub 2007 Jul 25.

    PMID: 17653742BACKGROUND

  • de Lapasse C, Rabischong B, Bolandard F, Canis M, Botchorischvili R, Jardon K, Mage G. Total laparoscopic hysterectomy and early discharge: satisfaction and feasibility study. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):20-5. doi: 10.1016/j.jmig.2007.08.608.

    PMID: 18262139BACKGROUND

  • McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

    PMID: 18165577BACKGROUND

  • Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

    PMID: 19561014BACKGROUND

  • El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.

    PMID: 19376789BACKGROUND

  • McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

    PMID: 17179269BACKGROUND

  • 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. doi: 10.1016/j.rapm.2005.10.006. No abstract available.

    PMID: 16418039BACKGROUND

  • Jankovic ZB, Pollard SG, Nachiappan MM. Continuous transversus abdominis plane block for renal transplant recipients. Anesth Analg. 2009 Nov;109(5):1710-1. doi: 10.1213/ANE.0b013e3181ba75d1. No abstract available.

    PMID: 19843821BACKGROUND

  • Fredrickson MJ, Seal P. Ultrasound-guided transversus abdominis plane block for neonatal abdominal surgery. Anaesth Intensive Care. 2009 May;37(3):469-72. doi: 10.1177/0310057X0903700303.

    PMID: 19499870BACKGROUND

  • Niraj G, Kelkar A, Fox AJ. Application of the transversus abdominis plane block in the intensive care unit. Anaesth Intensive Care. 2009 Jul;37(4):650-2. doi: 10.1177/0310057X0903700420.

    PMID: 19681428BACKGROUND

  • Preliminary experience with transversus abdominis plane block for postoperative pain relief in infants and children

    RESULT

MeSH Terms

Conditions

Bites and StingsPain

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Gustavo A Calle, MD

    CES University

    STUDY DIRECTOR

Central Study Contacts

Gustavo Adolfo Calle, Ginecólogo

CONTACT

5765700gustavocalle.md@gmail.com

Claudia López, Ginecóloga

CONTACT

3104365060cclopez04@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 11, 2012

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 11, 2012

Record last verified: 2012-05

Locations

CO(1)