Intrathecal Levobupivacaine With Opioids for Caesarean Section

NCT01858090 | Completed Phase 3 DMC

• 1 other identifier: KA08/48
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, double-blind, controlled study, the aim was to compare the effect of adding fentanyl (10 µg) or sufentanil (2.5 µg) to levobupivacaine (2.2±0.2 ml 0.5%) on the intraoperative anesthesia quality, block characteristics, the side effects on the newborn and mother, the duration of postoperative analgesia, and surgeon satisfaction score.

Conditions

Elective Caesarean Section Surgeries

Keywords

spinal anesthesia; caesarean section; local anesthetics; levobupivacaine; sufentanil; fentanyl; above 18 years of age; pregnant women; multiparous; nulliparous

Outcome Measures

Primary Outcomes (1)

• Comparison of the effect of adding fentanyl or sufentanil to levobupivacaine (2.2±0.2 ml 0.5%) on intraoperative anesthesia quality block characteristics side effects on newborn and mother,duration of postoperative analgesia,surgeon satisfaction score

  during caesarean section and postoperative first 24 hours

Other Outcomes (1)

• The time of first analgesic requirement

  Postoperative first 24 hours

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Control Group, Group C: Spinal anesthesia with levobupivacaine %0.5 (2.2±0.2 ml)+ Serum saline

Drug: Control Group Chirocaine; Drug: Ephedrine; Drug: Atropine sulfate; Drug: Propofol; Drug: Metoclopramide; Drug: Diphenhydramine; Drug: pethidine hydrochloride; Drug: Diclofenac sodium

Group Fentanyl

ACTIVE COMPARATOR

Group Fentanyl, Group F: Spinal anesthesia with levobupivacaine %0.5 (2.2±0.2 ml+fentanyl (10 µg)

Drug: Group Fentanyl; Drug: Ephedrine; Drug: Atropine sulfate; Drug: Propofol; Drug: Metoclopramide; Drug: Diphenhydramine; Drug: pethidine hydrochloride; Drug: Diclofenac sodium

Group sufentanil

ACTIVE COMPARATOR

Group sufentanil, Group S: spinal anesthesia with levobupivacaine %0.5 (2.2±0.2 ml)+ sufentanil (2.5 µg)

Drug: Group sufentanil; Drug: Ephedrine; Drug: Atropine sulfate; Drug: Propofol; Drug: Metoclopramide; Drug: Diphenhydramine; Drug: pethidine hydrochloride; Drug: Diclofenac sodium

Interventions

Control Group Chirocaine DRUG

Control group: Spinal anesthesia with levobupivacaine+Serum Physiologic %0.9 (Total volume 3 mL)

Also known as: Chirocaine, Chirocaine®, Abbott Laboratories, Ireland, 113/13, 16.12.2002, Serum Physiologic %0.9, Serum Fizyolojik %0.9 10 ml Ampul, Adeka İlac, 8699587751799

Control Group

Group Fentanyl DRUG

Also known as: Fentanyl®, Johnson&Johnson, USA, 110/53, 01.08.2001

Group Fentanyl

Group sufentanil DRUG

Also known as: Sufenta®, Johnson&Johnson, USA, 108/26, 15.08.2000

Group sufentanil

Ephedrine DRUG

If systolic blood pressure values decreased more than 20% with respect to the baseline values, or decreased to \<100 mmHg, fluid loading and ephedrine (5 mg) were administered.

Also known as: EFEDRİN HİDROKLORÜR AMPUL 0.05 g, 1 ml, 30.06.1999 - 192/42, OSEL İlaç San. ve Tic. A.Ş. Beykoz/İSTANBUL

Control Group; Group Fentanyl; Group sufentanil

Atropine sulfate DRUG

A decrease in heart rate to less than 55 beats/min was considered as bradycardia, and atropine (0.5 mg) was administered

Also known as: ATROPİN SÜLFAT AMPUL 1/4 mg, 1 ml, 30.06.1999 - 192/9, OSEL İlaç San. ve Tic. A.Ş. Beykoz/İSTANBUL

Control Group; Group Fentanyl; Group sufentanil

Propofol DRUG

Intravenous propofol (up to 0.5 mg/kg) was administered if patients had discomfort

Also known as: Propofol Ampul, Abbott Laboratories, USA, 23.12.1998 - 105/37

Control Group; Group Fentanyl; Group sufentanil

Metoclopramide DRUG

Metoclopramide (10 mg IV) was administered for nausea

Also known as: Metpamid Ampul, Üretici Firma:YENI ILAC VE HAMMADDELERI SANAYI VE TICARET A.S., Esenyurt/ISTANBUL, 300188-1 BR, Etken Madde(ler):Metoklopramid HCI 10 mg/2 ml

Control Group; Group Fentanyl; Group sufentanil

Diphenhydramine DRUG

for severe pruritus

Also known as: Benison Ampul, Osel İlaç, 8699788750300

Control Group; Group Fentanyl; Group sufentanil

pethidine hydrochloride DRUG

pethidine hydrochloride (50 mg IM) was administered as the first analgesic postoperatively

Also known as: Aldolan ampul, Liba Laboratuarları A.Ş., 20.12.1985 - 86/29, Gerot Pharmazeutika GmbH, Arnethgasse 3, 1171 Viyana, Avusturya

Control Group; Group Fentanyl; Group sufentanil

Diclofenac sodium DRUG

as additional analgesic among cases in which VAS\>3(Postoperatively)

Also known as: Diclomec Ampul 75 mg/ 3 ml, Mecom Saglik Urunleri San. ve Tic. A.S, 8699633759366

Control Group; Group Fentanyl; Group sufentanil

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• above 18 years of age
• gestational pregnancy age ≥ 36 weeks
• height ≥ 155 cm
• weight ≤110 kg
• fetal weight ≥ 2500 g)
• American Society of Anesthesiologists (ASA) Physical Status of I to II
• elective caesarean section surgeries were enrolled.

You may not qualify if:

• Local anesthetic allergy
• history of hypersensitivity and anaphylactic reactions
• emergency surgery
• preeclampsia

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

Related Publications (2)

• Karaman S, Kocabas S, Uyar M, Hayzaran S, Firat V. The effects of sufentanil or morphine added to hyperbaric bupivacaine in spinal anaesthesia for caesarean section. Eur J Anaesthesiol. 2006 Apr;23(4):285-91. doi: 10.1017/S0265021505001869. Epub 2006 Jan 27.

  PMID: 16438758 BACKGROUND

• Bozdogan Ozyilkan N, Kocum A, Sener M, Caliskan E, Tarim E, Ergenoglu P, Aribogan A. Comparison of intrathecal levobupivacaine combined with sufentanil, fentanyl, or placebo for elective caesarean section: a prospective, randomized, double-blind, controlled study. Curr Ther Res Clin Exp. 2013 Dec;75:64-70. doi: 10.1016/j.curtheres.2013.09.003.

  PMID: 24465046 DERIVED

MeSH Terms

Interventions

Levobupivacaine; Fentanyl; Sufentanil; Ephedrine; Atropine; Propofol; Metoclopramide; Diphenhydramine; Meperidine; Diclofenac

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Phenyl Ethers; Benzhydryl Compounds; Isonipecotic Acids; Acids, Heterocyclic; Phenylacetates

Study Officials

• Anis Aribogan, Prof., MD

  Baskent University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 21, 2013
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

TU (1)