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Labor PainNCT04141527

Spinal Sufentanil for Obstetric Analgesia

An observational study of Labor Pain, run by Lund University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Labor Pain
What is being tested?
Spinal analgesia
How many people
164 participants
Where
No sites listed yet
Study dates
15 Jun 2016to 21 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Intrathecal sufentanil for labor pain

Who cannot join

  • Demographic, obstetrical or neonatal data is missing

About this study

Official title: Spinal Sufentanil for Relief of Labor Pain in Primi- and Multiparous Parturients

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.

Read the detailed description

A total sample size of 150 parturients had been calculated to enable differences of at least 20 % versus 5.0 % in proportions of obstetrical and neonatal problems between (equal numbers of) primi- and multiparous mothers to be statistically confirmed with 80 % power and 95 % probability.

Descriptive parametric data is reported as mean ± standard deviation (SD), and descriptive non-parametric data as median with interquartile range (IQR). Proportions are reported in percent with 95 % confidence interval (CI).

Parametric data was compared with two-tailed unpaired student's t-test, and non-parametric data with the Mann-Whitney U-test. Proportions were analyzed with two-tailed Fisher's exact test.

Probability (P) values at < 0.05 were considered statistically significant.

Conditions
Labor Pain
Being tested
Spinal analgesia
Keywords
Labor, Intrathecal sufentanil, Obstetrical, Spinal analgesia
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal analgesiaProcedure or surgery

    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.

Study groups in NCT04141527
Study groupRoleWhat they receive
Primiparous women82 primiparous obstetrical patients given intrathecal sufentanil for labor pain.
Receives: Procedure: Spinal analgesia
Multiparous women82 multiparous obstetrical patients given intrathecal sufentanil for labor pain.
Receives: Procedure: Spinal analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal hypotension

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

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

  2. Fetal bradycardia

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

    Measured: During the first hour after spinal analgesia

  3. 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

    Measured: During the first hour after spinal analgesia

  4. Supplementary spinal analgesia

    Any use of spinal analgesia after primary spinal analgesia

    Measured: 24 hours after initial spinal analgesia

  5. Supplementary epidural analgesia

    Any use of epidural analgesia after primary spinal analgesia

    Measured: 24 hours after initial spinal analgesia

  6. Instrumental delivery

    Use of instrumental delivery

    Measured: During childbirth

  7. Intrapartum Cesarean section

    Use of intrapartum Cesarean section

    Measured: During childbirth

  8. Third- or fourth-degree perineal tear

    Rate of third- or fourth-degree perineal tear

    Measured: During childbirth

  9. Oxytocin before spinal analgesia

    Any use of oxytocin before spinal analgesia

    Measured: 24 hours before childbirth

  10. Oxytocin after spinal analgesia

    Any use of oxytocin after spinal analgesia

    Measured: 24 hours after spinal analgesia

  11. Maternal satisfaction with pain relief

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

    Measured: 24 hours after spinal analgesia

  12. Postspinal dural puncture headache

    Rate of postspinal dural puncture headache

    Measured: 48 hours after spinal analgesia

  13. Epidural blood patch

    Use of epidural blood patch

    Measured: 1 veek after spinal analgesia

Secondary outcomes (8)

  1. Low Apgar score of newborn (Apgar score ≤ 7 )

    Number of newborns with Apgar score ≤ 7

    Measured: One minute and 5 minutes after birth

  2. Use of neonatal intensive care

    Number of newborns requiring intensive care unit

    Measured: 1 week

  3. Breastfeeding

    Number of infants with breastfeeding

    Measured: 1 week

  4. Time from maternal arrival until request for SA

    Time in minutes

    Measured: During childbirth

  5. Time from request for SA until arrival of anaesthesiologist

    Time in minutes

    Measured: During childbirth

  6. Time from arrival of anaesthesiologist until SA

    Time in minutes

    Measured: During childbirth

  7. Time from SA until maximal cervical dilation

    Time in minutes

    Measured: During childbirth

  8. Time from maximal cervical dilation until delivery

    Time in minutes

    Measured: During childbirth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start15 Jun 2016
  3. Primary completion25 Aug 2016
  4. Study completion21 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141527
Sponsor's protocol ID
DNR2015/687
Status last verified
Sep 2020
First submitted
17 Oct 2019
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22419342

  • 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.

    PubMed 21320088

  • 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.

    PubMed 12969571

  • 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.

    PubMed 7618720

  • 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.

    PubMed 9972757

  • 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.

    PubMed 19329011

  • 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.

    PubMed 11605932

  • 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.

    PubMed 11379678

  • 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.

    PubMed 22420645

  • 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.

    PubMed 26333691

  • 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.

    PubMed 24738803

  • 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.

    PubMed 16235275

  • 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.

    PubMed 19482405

  • 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.

    PubMed 11213000

  • 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.

    PubMed 19945274

Questions about this trial

What is this clinical trial studying?

An observational study of Labor Pain, run by Lund University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal hypotension (time frame: During the first 20 minutes after spinal analgesia with 5 minutes intervals). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04141527, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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