Levobupivacaine to the Surgical Wound Following Cesarean

Postoperative Pain Clinical Trial

Official title:

Efficacy of Continuous Infusion of Levobupivacaine to the Surgical Wound Following Cesarean

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458431
• Other study ID #: MGR-LB-2010-01
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2011
• Last updated: December 20, 2014
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2011
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Levobupivacaine
continuous levobupivacaine subfascial infusion
• NaCl
continuous NaCl subfascial infusion

Locations

Country	Name	City	State
Spain	Teresa Herrera Hospital; A Coruña University Hospital Complex	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Ángel Gómez-Ríos

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View 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. Review. — View Citation

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. — View 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. — View 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. Epub 2006 Oct 25. Review. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area of incisional secondary hyperalgesia		72 hours	No
Secondary	Pain relief		72 hours	No
Secondary	consumption of morphine (mg) and paracetamol (gr)		48 hours	No
Secondary	Incidence of chronic pain		6 month	No
Secondary	Pharmacokinetic variables of levobupivacaine	Cmax, Area Under Curve, Tmax	72 hours	No
Secondary	Incidence of complications and/or side effects related to the technique		72 hours	Yes
Secondary	Rate of satisfaction experienced by the patients through a survey		72 hours	No
Secondary	endocrin-metabolic response		72 hours	No