Levobupivacaine to the Surgical Wound Following Cesarean - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain	Drug: continuous levobupivacaina subfascial infusion Drug: NaCl	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean

Further study details as provided by Complexo Hospitalario Universitario de A Coruña:

Primary Outcome Measures:

Area of incisional secondary hyperalgesia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain relief [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
consumption of morphine (mg) and paracetamol (gr) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Incidence of chronic pain [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Pharmacokinetic variables of levobupivacaine [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Cmax, Area Under Curve, Tmax
Incidence of complications and/or side effects related to the technique [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Rate of satisfaction experienced by the patients through a survey [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
endocrin-metabolic response [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	October 2011
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patients with continuous levobupivacaine infusion	Drug: continuous levobupivacaina subfascial infusion continuous levobupivacaina subfascial infusion Other Name: continuous levobupivacaina subfascial infusion
Placebo Comparator: Patients without local anesthetics	Drug: NaCl continuous NaCl subfascial infusion Other Name: continuous NaCl subfascial infusion

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458431

Contacts

Contact: Manuel Á gómez-Ríos, MD

0034636909413

magoris@hotmail.com

Locations

Spain
Teresa Herrera Hospital; A Coruña University Hospital Complex	Recruiting
A Coruña, Spain, 15008
Contact: Manuel Á Gómez-Ríos, MD

Sponsors and Collaborators

Manuel Ángel Gómez-Ríos

Investigators

Principal Investigator:

Manuel Á gómez-Ríos, MD

C.H.U. A Coruña

More Information

Publications:

Møiniche 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.

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.

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. Epub 2006 Oct 25. Review. No abstract available.

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.

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.

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.

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.

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. Review.

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. Review.

Dahl JB, Møiniche S, Kehlet H. Wound infiltration with local anaesthetics for postoperative pain relief. Acta Anaesthesiol Scand. 1994 Jan;38(1):7-14. Review. No abstract available.

Responsible Party:	Manuel Ángel Gómez-Ríos, Principal Investigator, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier:	NCT01458431 History of Changes
Other Study ID Numbers:	MGR-LB-2010-01
Study First Received:	October 17, 2011
Last Updated:	October 20, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Complexo Hospitalario Universitario de A Coruña:

cesarean section
wound infusion
Local anesthetic levobupivacaine
Pain management

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Levobupivacaine
Bupivacaine

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013