Clinical trial NCT01458431: Levobupivacaine to the Surgical Wound Following Cesarean
Official title: Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: cesarean section
wound infusion
Local anesthetic levobupivacaine
Pain management
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Area of incisional secondary hyperalgesia
timeFrame: 72 hours
Secondary outcomes:
measure: Pain relief
timeFrame: 72 hours
measure: consumption of morphine (mg) and paracetamol (gr)
timeFrame: 48 hours
measure: Incidence of chronic pain
timeFrame: 6 month
measure: Pharmacokinetic variables of levobupivacaine
timeFrame: 72 hours
measure: Incidence of complications and/or side effects related to the technique
timeFrame: 72 hours
measure: Rate of satisfaction experienced by the patients through a survey
timeFrame: 72 hours
measure: endocrin-metabolic response
timeFrame: 72 hours
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Teresa Herrera Hospital; A Coruña University Hospital Complex
Study officials:
affiliation: C.H.U. A Coruña
name: Manuel Á gómez-Ríos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.