Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04975659
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2021-07-02
Brief Title:
Placebo Versus Nocebo Effects on Pain and Anxiety During Local Anaesthetic Infiltration in Parturient Undergoing Elective Caesarean Delivery
Sponsor:
Universiti Kebangsaan Malaysia Medical Centre
Organization:
Universiti Kebangsaan Malaysia Medical Centre
Study Overview
Official Title:
Placebo Versus Nocebo Effects on Pain and Anxiety During Local Anaesthetic Infiltration in Parturient Undergoing Elective Caesarean Delivery
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized trial compared placebo and nocebo effect over anaesthetist-patient communication on pain and anxiety score during local anaesthetic LA skin infiltration in parturient undergoing caesarean delivery under regional anaesthesia RA A secondary objective was to determine if education level and previous RA experience affect pain and anxiety scores Parturients scheduled for elective caesarean delivery were randomised into Placebo P or Nocebo N group Baseline Amsterdam Preoperative Anxiety Information Scale APAIS0 were obtained Standardised scripts describing the LA skin infiltration for RA were used during the pre-anaesthetic review N group were explained with words like pain prick sharp while words like numb comfort tolerable were used in the P group avoiding painful expressions The same scripts will be repeated before skin infiltration during the RA procedure On the day of surgery a second APAIS1 was obtained upon arrival to the theatre Pain score using the numerical rating scale NRS was assessed after LA infiltration
Detailed Description:
We randomised participants into either the nocebo N or placebo P group We obtained a baseline anxiety score APAIS0 using the Amsterdam Preoperative Anxiety and Information Scale APAIS during the pre-anaesthesia visit Following that we informed subjects in the N group a negative suggestion using the following script During the local anaesthetic injection you are going to feel a sharp prick at your back this is usually the most painful part of the procedure On the other hand we used a positive suggestion on the P group We will administer some local anaesthetic to numb your back this will allow the procedure to be more comfortable and tolerable for you We obtain a second anxiety score APAIS1 in the operating theatre before the caesarean section We carried out either spinal anaesthesia or continuous spinal epidural according to standard hospital protocol and indication Before the LA skin infiltration the anaesthetist repeats the same script to the subjects according to the prior randomisation Five millilitres of lignocaine 2 is injected intradermally and subcutaneously by the anaesthetist into interspinous space in a single pass through a 22-gauge needle to create a skin wheal
During the LA infiltration only the attending anaesthetist performing the procedure gave participants verbal instructions other personnel remained silent throughout We recorded the presence of vocalisation of pain withdrawal movement or facial grimacing Immediately after the LA infiltration a blinded and trained general anaesthetic nurse or personnel enters the operating theatre to assess the subjects pain score using the numerical rating scale NRS After collection of the pain score the anaesthetist performed the remaining anaesthetic procedure as per clinical routine
During the LA infiltration only the attending anaesthetist performing the procedure gave participants verbal instructions other personnel remained silent throughout We recorded the presence of vocalisation of pain withdrawal movement or facial grimacing Immediately after the LA infiltration a blinded and trained general anaesthetic nurse or personnel enters the operating theatre to assess the subjects pain score using the numerical rating scale NRS After collection of the pain score the anaesthetist performed the remaining anaesthetic procedure as per clinical routine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None