Levobupivacaine to the Surgical Wound Following Cesarean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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cesarean section wound infusion Local anesthetic levobupivacaine Pain management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levobupivacaine

Continuous levobupivacaine subfascial infusion

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

continuous levobupivacaine subfascial infusion

NaCl

Continuous NaCl subfascial infusion

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

continuous NaCl subfascial infusion

Interventions

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Levobupivacaine

continuous levobupivacaine subfascial infusion

Intervention Type DRUG

NaCl

continuous NaCl subfascial infusion

Intervention Type DRUG

Other Intervention Names

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local anesthetic Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Manuel Ángel Gómez-Ríos

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Manuel Á gómez-Ríos, MD

Role: PRINCIPAL_INVESTIGATOR

C.H.U. A Coruña

Locations

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Teresa Herrera Hospital; A Coruña University Hospital Complex

A Coruña, A Coruña, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND

PMID: 9861124 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8717568 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17116561 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17525598 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16798442 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16980157 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12477585 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20460027 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19588413 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8140877 (View on PubMed)

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.

Reference Type DERIVED

PMID: 35086112 (View on PubMed)

Other Identifiers

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MGR-LB-2010-01

Identifier Type: -

Identifier Source: org_study_id

Levobupivacaine to the Surgical Wound Following Cesarean

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Levobupivacaine

Levobupivacaine

NaCl

NaCl

Interventions

Levobupivacaine

NaCl

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Manuel Ángel Gómez-Ríos

Responsible Party

Manuel Ángel Gómez-Ríos

Principal Investigators

Manuel Á gómez-Ríos, MD

Locations

Teresa Herrera Hospital; A Coruña University Hospital Complex

Countries

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

Other Identifiers

MGR-LB-2010-01