CClinicalTrials.gg
Sign In
CompletedNCT01458431Updated Dec 23, 2014

Levobupivacaine to the Surgical Wound Following Cesarean

A Phase 3 interventional study of Levobupivacaine and NaCl in Postoperative Pain, sponsored by Manuel Ángel Gómez-Ríos. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-12-23.

Sponsored by Manuel Ángel Gómez-Ríos · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Postoperative Pain

Browse trials for

Keywords

  • cesarean section
  • wound infusion
  • Local anesthetic levobupivacaine
  • Pain management
03

In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 70 is below the median of 80 across 412 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

Manuel Ángel Gómez-Ríos is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Levobupivacaine

    Continuous levobupivacaine subfascial infusion

    Drug: Levobupivacaine

  • Placebo comparator
    NaCl

    Continuous NaCl subfascial infusion

    Drug: NaCl

Interventions

  • DrugLevobupivacaine

    continuous levobupivacaine subfascial infusion

    Also known as: local anesthetic

  • DrugNaCl

    continuous NaCl subfascial infusion

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Area of incisional secondary hyperalgesia

    Time frame: 72 hours

Secondary outcomes

  1. Pain relief

    Time frame: 72 hours

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

    Time frame: 48 hours

  3. Incidence of chronic pain

    Time frame: 6 month

  4. Pharmacokinetic variables of levobupivacaine

    Cmax, Area Under Curve, Tmax

    Time frame: 72 hours

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

    Time frame: 72 hours

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

    Time frame: 72 hours

  7. endocrin-metabolic response

    Time frame: 72 hours

07

Study locations

1 site
  • Teresa Herrera Hospital; A Coruña University Hospital Complex
    A Coruña, 15008, Spain
08

References and documents

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;(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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01458431
Lead sponsor
Manuel Ángel Gómez-Ríos
Responsible party
Manuel Ángel Gómez-Ríos (Principal Investigator, Complexo Hospitalario Universitario de A Coruña) — Sponsor-investigator
First posted
Oct 24, 2011
Start date
Oct 2011
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Dec 23, 2014

Study contacts

Manuel Á gómez-Ríos, MD
principal investigator · C.H.U. A Coruña

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Surgical Wound→

Other studies from this sponsor

Manuel Ángel Gómez-Ríos

Start the discussion