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Levobupivacaine to the Surgical Wound Following Cesarean

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Levobupivacaine

NaCl

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cesarean section, wound infusion, Local anesthetic levobupivacaine, Pain management

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Teresa Herrera Hospital; A Coruña University Hospital Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levobupivacaine

NaCl

Arm Description

Continuous levobupivacaine subfascial infusion

Continuous NaCl subfascial infusion

Outcomes

Primary Outcome Measures

Area of incisional secondary hyperalgesia

Secondary Outcome Measures

Pain relief

consumption of morphine (mg) and paracetamol (gr)

Incidence of chronic pain

Pharmacokinetic variables of levobupivacaine

Cmax, Area Under Curve, Tmax

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

Rate of satisfaction experienced by the patients through a survey

endocrin-metabolic response

Full Information

NCT ID

NCT01458431

First Posted

October 17, 2011

Last Updated

December 20, 2014

Sponsor

Manuel Ángel Gómez-Ríos

1. Study Identification

Unique Protocol Identification Number

NCT01458431

Brief Title

Levobupivacaine to the Surgical Wound Following Cesarean

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Manuel Ángel Gómez-Ríos

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levobupivacaine

Arm Type

Experimental

Arm Description

Continuous levobupivacaine subfascial infusion

Arm Title

NaCl

Arm Type

Placebo Comparator

Arm Description

Continuous NaCl subfascial infusion

Intervention Type

Drug

Intervention Name(s)

Levobupivacaine

Other Intervention Name(s)

local anesthetic

Intervention Description

continuous levobupivacaine subfascial infusion

Intervention Type

Drug

Intervention Name(s)

NaCl

Other Intervention Name(s)

Placebo

Intervention Description

continuous NaCl subfascial infusion

Primary Outcome Measure Information:

Title

Area of incisional secondary hyperalgesia

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Pain relief

Time Frame

72 hours

Title

consumption of morphine (mg) and paracetamol (gr)

Time Frame

48 hours

Title

Incidence of chronic pain

Time Frame

6 month

Title

Pharmacokinetic variables of levobupivacaine

Description

Cmax, Area Under Curve, Tmax

Time Frame

72 hours

Title

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

Time Frame

72 hours

Title

Rate of satisfaction experienced by the patients through a survey

Time Frame

72 hours

Title

endocrin-metabolic response

Time Frame

72 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Á gómez-Ríos, MD

Organizational Affiliation

C.H.U. A Coruña

Official's Role

Principal Investigator

Facility Information:

Facility Name

Teresa Herrera Hospital; A Coruña University Hospital Complex

City

A Coruña

ZIP/Postal Code

15008

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

9861124

Citation

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.

Results Reference

background

PubMed Identifier

8717568

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. doi: 10.1111/j.1479-828x.1995.tb02156.x.

Results Reference

background

PubMed Identifier

17116561

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. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.

Results Reference

background

PubMed Identifier

17525598

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. doi: 10.1097/01.anes.0000267606.17387.1d.

Results Reference

background

PubMed Identifier

16798442

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. doi: 10.1016/j.ijoa.2006.02.003.

Results Reference

background

PubMed Identifier

16980157

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. doi: 10.1016/j.jclinane.2006.01.001.

Results Reference

background

PubMed Identifier

12477585

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. doi: 10.1016/s0952-8180(02)00422-1.

Results Reference

background

PubMed Identifier

20460027

Citation

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.

Results Reference

background

PubMed Identifier

19588413

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.

Results Reference

background

PubMed Identifier

8140877

Citation

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.

Results Reference

background

PubMed Identifier

35086112

Citation

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.

Results Reference

derived

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Levobupivacaine to the Surgical Wound Following Cesarean

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