Levobupivacaine to the Surgical Wound Following Cesarean
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Levobupivacaine Continuous levobupivacaine subfascial infusion |
Drug: Levobupivacaine
continuous levobupivacaine subfascial infusion
Other Names:
|
| Placebo Comparator: NaCl Continuous NaCl subfascial infusion |
Drug: NaCl
continuous NaCl subfascial infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area of incisional secondary hyperalgesia [72 hours]
Secondary Outcome Measures
- Pain relief [72 hours]
- consumption of morphine (mg) and paracetamol (gr) [48 hours]
- Incidence of chronic pain [6 month]
- Pharmacokinetic variables of levobupivacaine [72 hours]
Cmax, Area Under Curve, Tmax
- Incidence of complications and/or side effects related to the technique [72 hours]
- Rate of satisfaction experienced by the patients through a survey [72 hours]
- endocrin-metabolic response [72 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Full-term pregnant women who undergo scheduled cesarean surgery under intradural anesthesia.
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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.
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Between 18-45 years of age.
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ASA I and II.
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Sufficient intellectual ability to understand the technique as well as the equipment being used.
Exclusion Criteria:
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Failure to meet any of the above criteria.
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Presence of a major medical, cardiovascular, pulmonary, metabolic, renal or liver disorder.
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Preeclampsia and/or HELLP syndrome.
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Coagulopathy
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Profuse bleeding greater than 1000 ml or that which provokes hemodynamic instability that requires aggressive fluid therapy and/or transfusion.
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Allergy to any drug included in the protocol.
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Psychiatric or neurological pathology.
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Preexisting infection.
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Previous treatment with opioids or antidepressants or suffer from chronic pain.
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History of alcohol or drug abuse or known consumption of medications that interfere with LB metabolism.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Teresa Herrera Hospital; A Coruña University Hospital Complex | A Coruña | Spain | 15008 |
Sponsors and Collaborators
- Manuel Ángel Gómez-Ríos
Investigators
- Principal Investigator: Manuel Á gómez-Ríos, MD, C.H.U. A Coruña
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. doi: 10.1002/14651858.CD006954.pub2. 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.
- 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.
- 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.
- 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.
- 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.
- 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, 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.
- 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.
- MGR-LB-2010-01