Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primiparous women | 82 primiparous obstetrical patients given intrathecal sufentanil for labor pain. |
| |
| Multiparous women | 82 multiparous obstetrical patients given intrathecal sufentanil for labor pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal analgesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)\ | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Low Apgar score of newborn (Apgar score ≤ 7 ) | Number of newborns with Apgar score ≤ 7 | One minute and 5 minutes after birth |
| Use of neonatal intensive care | Number of newborns requiring intensive care unit |
Not provided
Inclusion Criteria:
Intrathecal sufentanil for labor pain
Exclusion Criteria:
Demographic, obstetrical or neonatal data is missing
Pregnant women in labor
Not provided
Not provided
Primi- and multiparous obstetrical patients at the maternity ward of the Central Hospital in Kristianstad, Sweden, between 7th January 2013 and 29th July 2016
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonas Åkeson, Professor | Lund University Skåne University Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22419342 | Background | 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. | |
| 21320088 | Background | 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. |
| Label | URL |
|---|---|
| Statistics on breastfeeding 2014. Statistics Sweden 2016 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2019 | Oct 16, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 1 week |
| Breastfeeding | Number of infants with breastfeeding | 1 week |
| Time from maternal arrival until request for SA | Time in minutes | During childbirth |
| Time from request for SA until arrival of anaesthesiologist | Time in minutes | During childbirth |
| Time from arrival of anaesthesiologist until SA | Time in minutes | During childbirth |
| Time from SA until maximal cervical dilation | Time in minutes | During childbirth |
| Time from maximal cervical dilation until delivery | Time in minutes | During childbirth |
| 12969571 | Background | 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. |
| 7618720 | Background | 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. |
| 9972757 | Background | 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. |
| 19329011 | Background | 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. |
| 11605932 | Background | 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. |
| 11379678 | Background | 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. |
| 22420645 | Background | 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. |
| 26333691 | Background | 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. |
| 24738803 | Background | 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. |
| 16235275 | Background | 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. |
| 19482405 | Background | 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. |
| 11213000 | Background | 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. |
| 19945274 | Background | 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. |
| 12734154 | Background | 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. |
| 14570796 | Background | 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. |
| 18691871 | Background | 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. |
| 9773697 | Background | 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. |
| 7943823 | Background | 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. |
| 9466102 | Background | 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. |
| 8087904 | Result | 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. |
| 8010467 | Result | 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. |
| 9174303 | Result | 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. |
| 11950182 | Result | 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. |
| 24922321 | Result | 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. |
| 18823774 | Result | 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. |
| 19912160 | Result | 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. |