AzTrials
AzTrials

Postoperative PainPhase 3NCT01458431

Levobupivacaine to the Surgical Wound Following Cesarean

A Phase 3 study testing Levobupivacaine and NaCl in people with Postoperative Pain, run by Manuel Ángel Gómez-Ríos at 1 site in Spain.

Completed

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

Official record
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Trial summary

The postoperative period following cesarean is associated with moderate to severe pain that requires a considerable amount of analgesics that carry with them side-effects such as nausea, vomiting, fatigue and immobilization. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Postoperative Pain
What is being tested?
Levobupivacaine and NaCl
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteSpain
Study dates
Oct 2011to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Full-term pregnant women who undergo scheduled cesarean surgery under intradural anesthesia.
  • Duly informed patients who have signed the informed consent during the preanesthesia consultation, or after a period of consideration if necessary, expressing their consent to be included in the study.
  • Between 18-45 years of age.
  • ASA I and II.
  • Sufficient intellectual ability to understand the technique as well as the equipment being used.

Who cannot join

  • Failure to meet any of the above criteria.
  • Presence of a major medical, cardiovascular, pulmonary, metabolic, renal or liver disorder.
  • Preeclampsia and/or HELLP syndrome.
  • Coagulopathy
  • Profuse bleeding greater than 1000 ml or that which provokes hemodynamic instability that requires aggressive fluid therapy and/or transfusion.
  • Allergy to any drug included in the protocol.
Show all 10Show fewer
  • Psychiatric or neurological pathology.
  • Preexisting infection.
  • Previous treatment with opioids or antidepressants or suffer from chronic pain.
  • History of alcohol or drug abuse or known consumption of medications that interfere with LB metabolism.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Teresa Herrera Hospital; A Coruña University Hospital Complex

    A Coruña, A Coruña, 15008

Other trials in Spain

About this study

Official title: Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean

The postoperative period following cesarean is associated with moderate to severe pain that requires a considerable amount of analgesics that carry with them side-effects such as nausea, vomiting, fatigue and immobilization. Several studies have tried, with variable results, to find a more effective analgesia alternative such as infusion of local anesthetics through a catheter in the surgical wound sinus, a practice that has currently been widely used in clinical practice. Despite existing references on its use in the postoperative period following cesareans there continues to be a lack of information on other aspects. The investigators study hypothesis is that the use of levobupivacaine in the surgical wound will reduce the surface of hyperalgesia compared to the control group.

Being tested
Levobupivacaine, NaCl
Keywords
cesarean section, wound infusion, Local anesthetic levobupivacaine, Pain management
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

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

  • LevobupivacaineDrug

    Also called local anesthetic

    continuous levobupivacaine subfascial infusion

  • NaClDrug

    Also called Placebo

    continuous NaCl subfascial infusion

Study groups in NCT01458431
Study groupRoleWhat they receive
LevobupivacaineExperimentalContinuous levobupivacaine subfascial infusion
Receives: Drug: Levobupivacaine
NaClPlacebo comparatorContinuous NaCl subfascial infusion
Receives: Drug: NaCl

What is being measured

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

  1. Area of incisional secondary hyperalgesia

    Measured: 72 hours

Secondary outcomes (7)

  1. Pain relief

    Measured: 72 hours

  2. consumption of morphine (mg) and paracetamol (gr)

    Measured: 48 hours

  3. Incidence of chronic pain

    Measured: 6 month

  4. Pharmacokinetic variables of levobupivacaine

    Cmax, Area Under Curve, Tmax

    Measured: 72 hours

  5. Incidence of complications and/or side effects related to the technique

    Measured: 72 hours

  6. Rate of satisfaction experienced by the patients through a survey

    Measured: 72 hours

  7. endocrin-metabolic response

    Measured: 72 hours

Timeline

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

  1. First posted24 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458431
Sponsor's protocol ID
MGR-LB-2010-01
Status last verified
Oct 2011
First submitted
17 Oct 2011
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.

    PubMed 9861124

  • Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21. doi: 10.1111/j.1479-828x.1995.tb02156.x.

    PubMed 8717568

  • Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.

    PubMed 17116561

  • Lavand'homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology. 2007 Jun;106(6):1220-5. doi: 10.1097/01.anes.0000267606.17387.1d.

    PubMed 17525598

  • Ranta PO, Ala-Kokko TI, Kukkonen JE, Ohtonen PP, Raudaskoski TH, Reponen PK, Rawal N. Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study. Int J Obstet Anesth. 2006 Jul;15(3):189-94. doi: 10.1016/j.ijoa.2006.02.003.

    PubMed 16798442

  • Zohar E, Shapiro A, Eidinov A, Fishman A, Fredman B. Postcesarean analgesia: the efficacy of bupivacaine wound instillation with and without supplemental diclofenac. J Clin Anesth. 2006 Sep;18(6):415-21. doi: 10.1016/j.jclinane.2006.01.001.

    PubMed 16980157

  • Zohar E, Luban I, Zunser I, Shapiro A, Jedeikin R, Fredman B. Patient-controlled bupivacaine wound instillation following cesarean section: the lack of efficacy of adjuvant ketamine. J Clin Anesth. 2002 Nov;14(7):505-11. doi: 10.1016/s0952-8180(02)00422-1.

    PubMed 12477585

  • Bamigboye AA, Hofmeyr GJ. Caesarean section wound infiltration with local anaesthesia for postoperative pain relief - any benefit? S Afr Med J. 2010 May 4;100(5):313-9. doi: 10.7196/samj.3716.

    PubMed 20460027

  • Bamigboye AA, Hofmeyr GJ. Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD006954. doi: 10.1002/14651858.CD006954.pub2.

    PubMed 19588413

  • Dahl JB, Moiniche S, Kehlet H. Wound infiltration with local anaesthetics for postoperative pain relief. Acta Anaesthesiol Scand. 1994 Jan;38(1):7-14. doi: 10.1111/j.1399-6576.1994.tb03830.x. No abstract available.

    PubMed 8140877

  • Gomez-Rios MA, Codesido-Barreiro P, Seco-Vilarino C, Calvin-Lamas M, Curt-Nuno F, Nieto-Serradilla L, Rabunal-Alvarez MT, Fernandez-Rodriguez F, Peteiro-Cartelle J, Pensado-Boo R, Bou G, Pensado-Castineiras A, Casans-Frances R. Wound Infusion of 0.35% Levobupivacaine Reduces Mechanical Secondary Hyperalgesia and Opioid Consumption After Cesarean Delivery: A Prospective, Randomized, Triple-Blind, Placebo-Controlled Trial. Anesth Analg. 2022 Apr 1;134(4):791-801. doi: 10.1213/ANE.0000000000005917.

    PubMed 35086112

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levobupivacaine and NaCl in people with Postoperative Pain, run by Manuel Ángel Gómez-Ríos at 1 site in Spain.

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 10 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area of incisional secondary hyperalgesia (time frame: 72 hours). 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 NCT01458431, which also lists 11 linked publications.

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 23 Dec 2014.

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