Analgesia in the Second Stage of Labour

Completed

• Conditions: Childbirth Experience; Urinary Retention; Pain, Obstetric; Satisfaction, Personal
• Interventions: Procedure: Pudendal nerve block

• Registration Number: NCT04391075
• Lead Sponsor: Oslo University Hospital

Brief Summary

This study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. It is an observational study and half of included primarous women recieve a pudendal block.

Detailed Description

Pudendal block is used when there is a need to alleviate pain in the final stage of labour:

* From fully dilated cervix to delivery of the child.

* Associated with pain as the foetus rotates and descends through the pelvis.

* End of second stage: the perineum dilates as the child is being born.

Pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.Pudendal block is an old and relatively simple method, but not well studied. The main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally.

The investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. The ASL (Analgesia in the Second stage of Labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-15
• Study First Posted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1007

Inclusion Criteria

• Norwegian-speaking/reading
• Primiparity
• Single pregnancy
• Vaginal birth
• Cephalic presentation
• ≥37+0
• Age ≥18 years

Exclusion Criteria

• Transferre from midwifery-led birth unit
• Allergy to local anaesthesia
• Not valid data on pudendal block

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	Pudendal nerve block	Pudendal nerve block provided

Primary Outcome Measures

Name	Time	Method
Childbirth experience	Responds to questionnaire 4-12 weeks after delivery.	Childbirth experience questionnaire (CEQ), total score on a scale from 1.0 to 4.0. Higher score means better experience.
Urinary retention	3 hours	Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours.

Secondary Outcome Measures

Name	Time	Method
Pain, obstetric	Responds to questionnaire 4-12 weeks after delivery.	Measured by Visual Analog Scale (VAS). Scale from 0 to 100, higher scpre means more pain.