Levobupivacaine to the Surgical Wound Following Cesarean

NCT01458431 | Completed Phase 3 DMC

• 1 other identifier: MGR-LB-2010-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

cesarean section; wound infusion; Local anesthetic levobupivacaine; Pain management

Outcome Measures

Primary Outcomes (1)

• Area of incisional secondary hyperalgesia

  72 hours

Secondary Outcomes (7)

• 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

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

  72 hours

Study Arms (2)

Levobupivacaine

EXPERIMENTAL

Continuous levobupivacaine subfascial infusion

Drug: Levobupivacaine

NaCl

PLACEBO COMPARATOR

Continuous NaCl subfascial infusion

Drug: NaCl

Interventions

Levobupivacaine DRUG

continuous levobupivacaine subfascial infusion

Also known as: local anesthetic

Levobupivacaine

NaCl DRUG

continuous NaCl subfascial infusion

Also known as: Placebo

NaCl

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manuel Ángel Gómez-Ríos: lead

Study Sites (1)

Teresa Herrera Hospital; A Coruña University Hospital Complex

A Coruña, A Coruña, 15008, Spain

Location

Related Publications (11)

• 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.

  PMID: 9861124 BACKGROUND

• 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.

  PMID: 8717568 BACKGROUND

• 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.

  PMID: 17116561 BACKGROUND

• 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.

  PMID: 17525598 BACKGROUND

• 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.

  PMID: 16798442 BACKGROUND

• 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.

  PMID: 16980157 BACKGROUND

• 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.

  PMID: 12477585 BACKGROUND

• 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.

  PMID: 20460027 BACKGROUND

• 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.

  PMID: 19588413 BACKGROUND

• 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.

  PMID: 8140877 BACKGROUND

• 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.

  PMID: 35086112 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Levobupivacaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Manuel Á gómez-Ríos, MD

  C.H.U. A Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2011-10

Locations

ES (1)