Spinal Sufentanil for Obstetric Analgesia

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141527
• Other study ID #: DNR2015/687
• Status: Completed
• Start date: June 15, 2016
• Est. completion date: June 21, 2017

Study information

• Verified date: September 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: June 21, 2017
• Est. primary completion date: August 25, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Intrathecal sufentanil for labor pain

Exclusion Criteria:

Demographic, obstetrical or neonatal data is missing

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• Spinal analgesia
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

References & Publications (28)

Abouleish A, Abouleish E, Camann W. Combined spinal-epidural analgesia in advanced labour. Can J Anaesth. 1994 Jul;41(7):575-8. — View Citation

Aneiros F, Vazquez M, Valiño C, Taboada M, Sabaté S, Otero P, Costa J, Carceller J, Vázquez R, Díaz-Vieito M, Rodríguez 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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2011;(12):CD000331. — View Citation

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. — View Citation

Campbell DC, Camann WR, Datta S. The addition of bupivacaine to intrathecal sufentanil for labor analgesia. Anesth Analg. 1995 Aug;81(2):305-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Harsten A, Gillberg L, Håkansson L, Olsson M. Intrathecal sufentanil compared with epidural bupivacaine analgesia in labour. Eur J Anaesthesiol. 1997 Nov;14(6):642-5. — View Citation

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. — View Citation

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. — View Citation

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;(3):CD009234. doi: 10.1002/14651858.CD009234.pub2. Review. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Mardirosoff C, Dumont L, Boulvain M, Tramèr MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. Review. — View Citation

Norris MC, Fogel ST, Conway-Long C. Combined spinal-epidural versus epidural labor analgesia. Anesthesiology. 2001 Oct;95(4):913-20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. Review. — View Citation

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. — View Citation

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. — View Citation

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. 20 — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Late fetal deceleration	FHR(fetal heart rate)	During the first hour after spinal analgesia
Primary	Supplementary spinal analgesia	Any use of spinal analgesia after primary spinal analgesia	24 hours after initial spinal analgesia
Primary	Supplementary epidural analgesia	Any use of epidural analgesia after primary spinal analgesia	24 hours after initial spinal analgesia
Primary	Instrumental delivery	Use of instrumental delivery	During childbirth
Primary	Intrapartum Cesarean section	Use of intrapartum Cesarean section	During childbirth
Primary	Third- or fourth-degree perineal tear	Rate of third- or fourth-degree perineal tear	During childbirth
Primary	Oxytocin before spinal analgesia	Any use of oxytocin before spinal analgesia	24 hours before childbirth
Primary	Oxytocin after spinal analgesia	Any use of oxytocin after spinal analgesia	24 hours after spinal analgesia
Primary	Maternal satisfaction with pain relief	Defined by parturient after delivery as very god, god, less satisfactory or bad	24 hours after spinal analgesia
Primary	Postspinal dural puncture headache	Rate of postspinal dural puncture headache	48 hours after spinal analgesia
Primary	Epidural blood patch	Use of epidural blood patch	1 veek after spinal analgesia
Secondary	Low Apgar score of newborn (Apgar score = 7 )	Number of newborns with Apgar score = 7	One minute and 5 minutes after birth
Secondary	Use of neonatal intensive care	Number of newborns requiring intensive care unit	1 week
Secondary	Breastfeeding	Number of infants with breastfeeding	1 week
Secondary	Time from maternal arrival until request for SA	Time in minutes	During childbirth
Secondary	Time from request for SA until arrival of anaesthesiologist	Time in minutes	During childbirth
Secondary	Time from arrival of anaesthesiologist until SA	Time in minutes	During childbirth
Secondary	Time from SA until maximal cervical dilation	Time in minutes	During childbirth
Secondary	Time from maximal cervical dilation until delivery	Time in minutes	During childbirth

External Links

•   Statistics on breastfeeding 2014. Statistics Sweden 2016