Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

Labor Pain Clinical Trial

Official title:

Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389945
• Other study ID #: 922/17
• Status: Completed
• Phase: N/A
• Start date: January 13, 2018
• Est. completion date: March 19, 2019

Study information

• Verified date: June 2020
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. When compared with conventional epidural block, it provides improved sacral block and onset of analgesia.

Despite the benefits associated, the supportive literature remains scarce. No trial has determined if similar results could be obtained with a smaller needle.

In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS). The hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 19, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• healthy pregnant woman

• singleton and vertex presentation

• 37-42 weeks of gestational age

• active labor with cervical dilation < 5cm

• body mass index between 20 and 35 kg/m2

• desired labor epidural analgesia

Exclusion Criteria:

• adults who are unable to give their own consent

• presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)

• known fetal anomalies

• increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)

• coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets = 100, International Normalized Ratio = 1.4 or partial prothrombin time = 50)

• renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine = 100)

• hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases = 100)

• allergy to LA

• prior sacral or lumbar spine surgery

Related Conditions & MeSH terms

• Epidural Analgesia
• Labor Pain

Intervention

Procedure:
• 25G Dural Puncture Epidural Block
Dural puncture epidural analgesia using a 25G pencil point spinal needle at a lumbar interspace. Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space.
• 27G Dural Puncture Epidural Block
Dural puncture epidural analgesia using a 27G pencil point spinal needle at a lumbar interspace. Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitana
Chile	Hospital La Florida	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (7)

Beilin Y, Zahn J, Bernstein HH, Zucker-Pinchoff B, Zenzen WJ, Andres LA. Treatment of incomplete analgesia after placement of an epidural catheter and administration of local anesthetic for women in labor. Anesthesiology. 1998 Jun;88(6):1502-6. — View Citation

Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14. — View Citation

Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798. — View Citation

Landau R, Ciliberto CF, Goodman SR, Kim-Lo SH, Smiley RM. Complications with 25-gauge and 27-gauge Whitacre needles during combined spinal-epidural analgesia in labor. Int J Obstet Anesth. 2001 Jul;10(3):168-71. — View Citation

Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. — View Citation

Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. — View Citation

Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic data	Age, height, weight, BMI	At the time of recruitment
Primary	Time to pain = 1 on NRS (0-10)	Time elapsed between the end of local anesthetic injection and achievement of pain = 1 on the NRS (measured every 2 minutes)	Up to 30 minutes after local anesthetic injection
Secondary	Gestational age	Gestational age at the time of recruitment	42 weeks
Secondary	Obstetric history	Number of previous pregnancies and deliveries	At the time of recruitment
Secondary	Type of labor	Spontaneous versus induced labor	At the time of delivery
Secondary	Oxytocin dose	Oxytocin infusion/dose at time of DPE	At the time of DPE
Secondary	Cervical dilation	Cervical dilation at the time of DPE	At the time of DPE
Secondary	State of membrane	Intact versus ruptured membrane at the time of DPE	At the time of DPE
Secondary	Pre-DPE level of pain	Evaluated with a NRS from 0 to 10	Immediate before DPE
Secondary	Amount of IV fluids	Total intravenous fluid received during labor (from admission to the obstetric suite up to delivery)	24 hours
Secondary	Intervertebral level of puncture	Lumbar interspace where DPE was successfully performed	At the time of DPE
Secondary	Number of DPE attempts	Number of attempts for successful DPE	1 hour
Secondary	Incidence of accidental dural puncture	Incidence of accidental dural puncture with the epidural Tuohy needle	1 hour
Secondary	Performance time	Temporal interval between skin disinfection and epidural catheter fixation to the skin	1 hour
Secondary	Sensory block height	Sensory block height at 30 minutes after local anesthetic injection	Up to 30 minutes after local anesthetic injection
Secondary	Bilateral S2 sacral root block	Measured every 2 minutes after local anesthetic injection	Up to 30 minutes after local anesthetic injection
Secondary	Presence of motor block	Evaluated using a modified Bromage score	Up to 30 minutes after local anesthetic injection
Secondary	Number of epidural top-ups during labor	Number of extra doses of local anesthetic given after DPE up to delivery	After DPE up to delivery
Secondary	Type of delivery	Incidence of Cesarean section, normal delivery, and instrumented delivery	Delivery
Secondary	Incidence of epidural catheter adjustment or replacement	Necessity of adjustment or replacement of the epidural catheter	After DPE up to delivery
Secondary	DPE side effects	Incidence of nausea, pruritus, hypotension	After DPE up to delivery
Secondary	Fetal-Uterine assessment	Frequency of contractions, uterine tonus, fetal heart rate tracing	Before and up to 1 hour after DPE
Secondary	Tocolysis requirement	Necessity to administer a tocolytic agent after DPE	Up to 1 hour after DPE
Secondary	Apgar scores	Assessment of newborn condition	At 1 and 5 minutes after delivery
Secondary	DPE complications	Incidence of post dural puncture headache, back pain, paresthesia and motor deficit	After DPE up to 7 days postpartum
Secondary	Epidural blood patch incidence	Necessity of performing of a blood patch to relieve post dural puncture headache symptoms	Up to 1 week of followup