Perineal Local Infiltration Study

NCT03672500 | Terminated DMC

• 1 other identifier: PLIS_1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain, and result in emotional stress, difficulties in ambulation and breastfeeding, and more. The research team hypothesis is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain, prevent such difficulties, and improve women's overall well-being and satisfaction. The proposed trial is a two-arm, single-masked, randomized trial. Women with a working epidural analgesia, and a laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get no injection. The differences in perineal pain between the groups will be evaluated at 6 hours after last epidural dose.

Conditions

Second Degree Perineal Tear During Delivery - Delivered; Episiotomy; Complications; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Proportion of women who have a Numeric Rating Scale (NRS) score≤4 at 6-hours (±30 minutes) after last epidural bolus (comparison between bupivacaine arm and the no analgesic arm)

  Comparison between the bupivacaine arm and the no analgesic arm in terms of pain score at 6-hours.

  6-hours (±30 minutes) after last epidural bolus.

Other Outcomes (7)

• Time to first ambulation (getting out of bed).

  24 hours

• Number of administration of additional analgesics in the first 24 hours after last epidural bolus.

  24 hours

• NRS (Numeric Rating Scale, 0-10, acceptable if < 3) at 12 and 24 hours (±30 minutes) after last epidural bolus

  12 and 24 hours

Study Arms (2)

Bupivacaine arm

ACTIVE COMPARATOR

The edges of the 2PT/Epi will be infiltrated with 10ml of Bupivacaine 0.5%+Epinephrine 50mcg prior to suture placement.

Drug: Bupivacaine 0.5%+Epinephrine 50mc

Control arm

SHAM COMPARATOR

Sham injection will be done using a syringe filled with 10ml of NaCl 0.9%, but the fluid will not be injected to the edges of the laceration but discarded. The sham injection will last no less than 10 seconds.

Other: Sham injection

Interventions

Bupivacaine 0.5%+Epinephrine 50mc DRUG

Local infiltration of the perineum with Bupivacaine 0.5%+Epinephrine 50mc

Bupivacaine arm

Sham injection OTHER

Sham injection of the perineum

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age \> 18 years of age
• Gestational age≥34 weeks of gestation
• Vaginal delivery
• Perineal laceration (2PT/Epi)
• Effective epidural anesthesia
• No known hypersensitivity to bupivacaine or amino-amide anesthetics

You may not qualify if:

• Medical history of a chronic pain syndrome
• Intrapartum morphine use

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

• Khan GQ, Lilford RJ. Wound pain may be reduced by prior infiltration of the episiotomy site after delivery under epidural analgesia. Br J Obstet Gynaecol. 1987 Apr;94(4):341-4. doi: 10.1111/j.1471-0528.1987.tb03102.x.

  PMID: 3580317 BACKGROUND

• Schinkel N, Colbus L, Soltner C, Parot-Schinkel E, Naar L, Fournie A, Granry JC, Beydon L. Perineal infiltration with lidocaine 1%, ropivacaine 0.75%, or placebo for episiotomy repair in parturients who received epidural labor analgesia: a double-blind randomized study. Int J Obstet Anesth. 2010 Jul;19(3):293-7. doi: 10.1016/j.ijoa.2009.11.005. Epub 2010 Jun 2.

  PMID: 20627696 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amir Aviram, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: a randomized, single-masked, controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, single-masked, controlled trial

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: September 14, 2018
• Study Start: September 14, 2018
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CA (1)