Analgesia in the Second Stage of Labour

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analgesia in the Second Stage of Labour - With Special Focus on Pudendal Block

Conditions
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Childbirth Experience, Urinary Retention, Satisfaction, Personal, Pain, Obstetric

Intervention / Treatment
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* Procedure: Pudendal nerve block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Pudendal nerve block provided | Procedure: Pudendal nerve block<br>* Pudendal nerve block provided during last fase of delivery<br>|
| Not exposed<br>Pudendal nerve block is NOT provided | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Pudendal nerve block, Urine and urination, Peripheral nervous system agents