NCT04141527

Brief Summary

Background: This descriptive study was designed to evaluate effects and adverse effects of spinal sufentanil for relief of labor pain in primi- and multiparous women. Methods: The retrospective study design was approved by the regional Human Research Ethics Review Board, Lund, Sweden (Dnr 2015/687). The investigators included 164 (82 primi- and 82 multiparous) obstetrical patients given 10 µg of intrathecal sufentanil for labor pain. Any maternal hypotension, third- or fourth-degree perineal tear, intrapartum Cesarean section, abnormal fetal heart rate, low Apgar score, use of neonatal intensive care, postdural puncture headache, epidural blood patch, and breastfeeding problem was recorded. Major outcome measures were maternal satisfaction with pain relief, and provision of supplementary analgesia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

October 17, 2019

Last Update Submit

September 1, 2020

Conditions

Labor Pain

Keywords

LaborIntrathecal sufentanilObstetricalSpinal analgesia

Outcome Measures

Primary Outcomes (13)

  • Maternal hypotension

    Any fall in systolic pressure to \<100 mmHg or a decrease \>20% from the baseline level

    During the first 20 minutes after spinal analgesia with 5 minutes intervals

  • Fetal bradycardia

    A decrease in FHR(fetal heart rate) to 80 beats/ min for duration of 2 or more

    During the first hour after spinal analgesia

  • Late fetal deceleration

    FHR(fetal heart rate)\<FHR 40 min beats/ min below the baseline or less than 90/beats min for duration of 2 minutes or more

    During the first hour after spinal analgesia

  • Supplementary spinal analgesia

    Any use of spinal analgesia after primary spinal analgesia

    24 hours after initial spinal analgesia

  • Supplementary epidural analgesia

    Any use of epidural analgesia after primary spinal analgesia

    24 hours after initial spinal analgesia

  • Instrumental delivery

    Use of instrumental delivery

    During childbirth

  • Intrapartum Cesarean section

    Use of intrapartum Cesarean section

    During childbirth

  • Third- or fourth-degree perineal tear

    Rate of third- or fourth-degree perineal tear

    During childbirth

  • Oxytocin before spinal analgesia

    Any use of oxytocin before spinal analgesia

    24 hours before childbirth

  • Oxytocin after spinal analgesia

    Any use of oxytocin after spinal analgesia

    24 hours after spinal analgesia

  • Maternal satisfaction with pain relief

    Defined by parturient after delivery as very god, god, less satisfactory or bad

    24 hours after spinal analgesia

  • Postspinal dural puncture headache

    Rate of postspinal dural puncture headache

    48 hours after spinal analgesia

  • Epidural blood patch

    Use of epidural blood patch

    1 veek after spinal analgesia

Secondary Outcomes (8)

  • Low Apgar score of newborn (Apgar score ≤ 7 )

    One minute and 5 minutes after birth

  • Use of neonatal intensive care

    1 week

  • Breastfeeding

    1 week

  • Time from maternal arrival until request for SA

    During childbirth

  • Time from request for SA until arrival of anaesthesiologist

    During childbirth

  • +3 more secondary outcomes

Study Arms (2)

Primiparous women

82 primiparous obstetrical patients given intrathecal sufentanil for labor pain.

Procedure: Spinal analgesia

Multiparous women

82 multiparous obstetrical patients given intrathecal sufentanil for labor pain.

Procedure: Spinal analgesia

Interventions

Spinal analgesiaPROCEDURE

Spinal analgesia (SA) was provided by a resident or specialist anaesthesiologist with the patient in a sitting or a recumbent position. A pencil-point needle, primarily 27 G (0.4 mm), otherwise 25 G (0.5 mm), was used for transdermal intrathecal administration of 2.0 ml of sufentanil 5 µg/ml (Sufenta®, Janssen-Cilag AB, Solna, Sweden) at low-lumbar level. Blood pressure was recorded before, immediately after, and at five-minute intervals for 20 minutes after the block. Any decrease in systolic pressure to \<100 mmHg or a decrease \>20% from the baseline level despite infusion of crystalloid was defined to indicate maternal hypotension.

Multiparous womenPrimiparous women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women in labor
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primi- and multiparous obstetrical patients at the maternity ward of the Central Hospital in Kristianstad, Sweden, between 7th January 2013 and 29th July 2016

You may qualify if:

  • Intrathecal sufentanil for labor pain

You may not qualify if:

  • Demographic, obstetrical or neonatal data is missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (28)

  • Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

    PMID: 22419342BACKGROUND

  • Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.

    PMID: 21320088BACKGROUND

  • Eriksson SL, Blomberg I, Olofsson C. Single-shot intrathecal sufentanil with bupivacaine in late labour--analgesic quality and obstetric outcome. Eur J Obstet Gynecol Reprod Biol. 2003 Oct 10;110(2):131-5. doi: 10.1016/s0301-2115(03)00049-6.

    PMID: 12969571BACKGROUND

  • Campbell DC, Camann WR, Datta S. The addition of bupivacaine to intrathecal sufentanil for labor analgesia. Anesth Analg. 1995 Aug;81(2):305-9. doi: 10.1097/00000539-199508000-00017.

    PMID: 7618720BACKGROUND

  • Sia AT, Chong JL, Chiu JW. Combination of intrathecal sufentanil 10 mug plus bupivacaine 2.5 mg for labor analgesia: is half the dose enough? Anesth Analg. 1999 Feb;88(2):362-6. doi: 10.1097/00000539-199902000-00026.

    PMID: 9972757BACKGROUND

  • Aneiros F, Vazquez M, Valino C, Taboada M, Sabate S, Otero P, Costa J, Carceller J, Vazquez R, Diaz-Vieito M, Rodriguez A, Alvarez J. Does epidural versus combined spinal-epidural analgesia prolong labor and increase the risk of instrumental and cesarean delivery in nulliparous women? J Clin Anesth. 2009 Mar;21(2):94-7. doi: 10.1016/j.jclinane.2008.06.020.

    PMID: 19329011BACKGROUND

  • Norris MC, Fogel ST, Conway-Long C. Combined spinal-epidural versus epidural labor analgesia. Anesthesiology. 2001 Oct;95(4):913-20. doi: 10.1097/00000542-200110000-00020.

    PMID: 11605932BACKGROUND

  • Stocks GM, Hallworth SP, Fernando R, England AJ, Columb MO, Lyons G. Minimum local analgesic dose of intrathecal bupivacaine in labor and the effect of intrathecal fentanyl. Anesthesiology. 2001 Apr;94(4):593-8; discussion 5A. doi: 10.1097/00000542-200104000-00011.

    PMID: 11379678BACKGROUND

  • Patel NP, Armstrong SL, Fernando R, Columb MO, Bray JK, Sodhi V, Lyons GR. Combined spinal epidural vs epidural labour analgesia: does initial intrathecal analgesia reduce the subsequent minimum local analgesic concentration of epidural bupivacaine? Anaesthesia. 2012 Jun;67(6):584-93. doi: 10.1111/j.1365-2044.2011.07045.x. Epub 2012 Mar 15.

    PMID: 22420645BACKGROUND

  • Valensise H, Lo Presti D, Tiralongo GM, Pisani I, Gagliardi G, Vasapollo B, Frigo MG. Foetal heart rate deceleration with combined spinal-epidural analgesia during labour: a maternal haemodynamic cardiac study. J Matern Fetal Neonatal Med. 2016;29(12):1980-6. doi: 10.3109/14767058.2015.1072156. Epub 2015 Aug 28.

    PMID: 26333691BACKGROUND

  • Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.

    PMID: 24738803BACKGROUND

  • Anim-Somuah M, Smyth R, Howell C. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000331. doi: 10.1002/14651858.CD000331.pub2.

    PMID: 16235275BACKGROUND

  • Laine K, Gissler M, Pirhonen J. Changing incidence of anal sphincter tears in four Nordic countries through the last decades. Eur J Obstet Gynecol Reprod Biol. 2009 Sep;146(1):71-5. doi: 10.1016/j.ejogrb.2009.04.033. Epub 2009 May 30.

    PMID: 19482405BACKGROUND

  • Howell CJ, Kidd C, Roberts W, Upton P, Lucking L, Jones PW, Johanson RB. A randomised controlled trial of epidural compared with non-epidural analgesia in labour. BJOG. 2001 Jan;108(1):27-33. doi: 10.1111/j.1471-0528.2001.00012.x.

    PMID: 11213000BACKGROUND

  • Cooper GM, MacArthur C, Wilson MJ, Moore PA, Shennan A; COMET Study Group UK. Satisfaction, control and pain relief: short- and long-term assessments in a randomised controlled trial of low-dose and traditional epidurals and a non-epidural comparison group. Int J Obstet Anesth. 2010 Jan;19(1):31-7. doi: 10.1016/j.ijoa.2009.05.004. Epub 2009 Nov 27.

    PMID: 19945274BACKGROUND

  • Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9. doi: 10.1007/BF03021057.

    PMID: 12734154BACKGROUND

  • Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.

    PMID: 14570796BACKGROUND

  • Van de Velde M, Schepers R, Berends N, Vandermeersch E, De Buck F. Ten years of experience with accidental dural puncture and post-dural puncture headache in a tertiary obstetric anaesthesia department. Int J Obstet Anesth. 2008 Oct;17(4):329-35. doi: 10.1016/j.ijoa.2007.04.009. Epub 2008 Aug 8.

    PMID: 18691871BACKGROUND

  • Camann W, Abouleish A, Eisenach J, Hood D, Datta S. Intrathecal sufentanil and epidural bupivacaine for labor analgesia: dose-response of individual agents and in combination. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):457-62. doi: 10.1016/s1098-7339(98)90027-x.

    PMID: 9773697BACKGROUND

  • Clarke VT, Smiley RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labor: a cause of fetal bradycardia? Anesthesiology. 1994 Oct;81(4):1083. doi: 10.1097/00000542-199410000-00041. No abstract available.

    PMID: 7943823BACKGROUND

  • Harsten A, Gillberg L, Hakansson L, Olsson M. Intrathecal sufentanil compared with epidural bupivacaine analgesia in labour. Eur J Anaesthesiol. 1997 Nov;14(6):642-5. doi: 10.1046/j.1365-2346.1994.00212.x.

    PMID: 9466102BACKGROUND

  • Abouleish A, Abouleish E, Camann W. Combined spinal-epidural analgesia in advanced labour. Can J Anaesth. 1994 Jul;41(7):575-8. doi: 10.1007/BF03009995.

    PMID: 8087904RESULT

  • D'Angelo R, Anderson MT, Philip J, Eisenach JC. Intrathecal sufentanil compared to epidural bupivacaine for labor analgesia. Anesthesiology. 1994 Jun;80(6):1209-15. doi: 10.1097/00000542-199406000-00007.

    PMID: 8010467RESULT

  • Herman NL, Calicott R, Van Decar TK, Conlin G, Tilton J. Determination of the dose-response relationship for intrathecal sufentanil in laboring patients. Anesth Analg. 1997 Jun;84(6):1256-61. doi: 10.1097/00000539-199706000-00016.

    PMID: 9174303RESULT

  • Mardirosoff C, Dumont L, Boulvain M, Tramer MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. doi: 10.1111/j.1471-0528.2002.01380.x.

    PMID: 11950182RESULT

  • Everaert N, Coppens M, Vlerick P, Braems G, Wouters P, De Hert S. Combined spinal epidural analgesia for labor using sufentanil epidurally versus intrathecally: a retrospective study on the influence on fetal heart trace. J Perinat Med. 2015 Jul;43(4):481-4. doi: 10.1515/jpm-2014-0077.

    PMID: 24922321RESULT

  • Junttila EK, Karjalainen PK, Ohtonen PP, Raudaskoski TH, Ranta PO. A comparison of paracervical block with single-shot spinal for labour analgesia in multiparous women: a randomised controlled trial. Int J Obstet Anesth. 2009 Jan;18(1):15-21. doi: 10.1016/j.ijoa.2008.01.020. Epub 2008 Sep 26.

    PMID: 18823774RESULT

  • Wilson MJ, MacArthur C, Cooper GM, Bick D, Moore PA, Shennan A; COMET Study Group UK. Epidural analgesia and breastfeeding: a randomised controlled trial of epidural techniques with and without fentanyl and a non-epidural comparison group. Anaesthesia. 2010 Feb;65(2):145-53. doi: 10.1111/j.1365-2044.2009.06136.x. Epub 2009 Nov 12.

    PMID: 19912160RESULT

Related Links

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jonas Åkeson, Professor

    Lund University Skåne University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 28, 2019

Study Start

June 15, 2016

Primary Completion

August 25, 2016

Study Completion

June 21, 2017

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share