Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06044103 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Patient Satisfaction | Drug: PDB + PCS | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Does Adding Patient-controlled Sedation With Propofol During Repair of Obstetric Perineal Lacerations Grade I and II Improve Patient Experiences - a Randomized Control Trial |
Actual Study Start Date : | September 20, 2023 |
Estimated Primary Completion Date : | May 30, 2024 |
Estimated Study Completion Date : | October 30, 2024 |
Arm | Intervention/treatment |
---|---|
No Intervention: Control
Clinical routine
|
|
Experimental: Patient-controlled sedation with propofol
PCS group
|
Drug: PDB + PCS
Pudendal nerve block (PNB) with ropivacaine AND Patient-controlled sedation with propofol by the participant |
- Pain/discomfort (perprocedural) [ Time Frame: From randomization up to 2 hours. Measuring starts when the procedure with examination and repair of the laceration starts. Evaluation will be done immediately after procedure when criteria of fully recovered (OAA/S 5) is fulfilled. ]
Perprocedural pain/discomfort; is a composite variable consisting measurements of pain and discomfort:
Pain; measured with a VAS-scale (0-100 mm, "No pain" to "Worst imaginable pain") Discomfort; measured with a VAS-scale (0-100 mm, "No discomfort" to "Worst imaginable discomfort").
- Preprocedural anxiety [ Time Frame: From randomization up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5). ]Anxiety; measured with a VAS-scale (0-100 mm, "No anxiety" to "Worst imaginable anxiety").
- Perprocedural anxiety [ Time Frame: From randomization Up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5). ]Anxiety; measured with a VAS-scale (0-100 mm, "No anxiety" to "Worst imaginable anxiety").
- Patient experiences [ Time Frame: From randomization Up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5). ]Patient experiences (postprocedural) is measured using a study specific instrument.
- Time of repair the perineal laceration [ Time Frame: From randomization Up to 2 hours. Time for the procedure, the time between first attempt to suture until last suture. ]Time of repair the perineal laceration.
- Ability to have skin-to-skin contact with baby during perineal repair [ Time Frame: From randomization Up to 2 hours. The evaluation is made immediately after procedure completion. ]
Ability to have skin-to-skin contact with baby during perineal repair; will recorded using a 4-point Likert scale with the items 1 (none), 2 (less than half of the procedure), 3 (more than half of the procedure) and 4 (during the whole procedure).
Measured by the midwife.
- Procedure feasibility (perprocedural) [ Time Frame: From randomization Up to 2 hours.The evaluation is made immediately after procedure completion. ]
Procedure feasibility (perprocedural) consists of several variables:
Need of assistance from midwife; measured with a 3-items Likert scale (0="Not at all", 1="Partly", 2="Mostly") Need of assistance from partner; measured with a 3-items Likert scale (0="Not at all", 1="Partly", 2="Mostly", N/A) Ease of use; measured with a 4-items Likert scale (0="Easy", 1="Some difficulty", 2="Difficult", 3="Very difficult") Feasibility of PDB; 4-items Likert scale (0="Easy without any restrictions", 1="With somw difficulty but satisfactory result", 2="With som difficulty and impact on the result", 3="Had to cancel the procedure") Collaboration; measured with a 4-items Likert scale (0="None", 1="Minimal", 2="Moderate", 3="Significant") Defensive reactions/motions; measured with a 4-items Likert scale (0="None", 1="Minimal", 2="Moderate", 3="Significant") Overall satisfaction; measured with a 4-items Likert scale (0=" Satisfied", 1=" Neither satisfied nor dissatisfied/", 2=" Dissatisfied")
- Amount of drugs used during perineal repair [ Time Frame: From randomization Up to 2 hours. The evaluation is made immediately after procedure completion. ]Amount of drugs used during perineal repair; all drugs used during the procedure including PNB.
- Time until micturition after the perineal repair [ Time Frame: Time from randomization until 24 hours after. Evalutation time between completion of procedure until first in-ward micturition. ]Time until micturition after the perineal repair; is defined as time between completion of procedure until first in-ward micturition reported by the research person to staff.
- Use of pain-relieving drugs 24h postpartum [ Time Frame: On Day 1 after randomization. Evaluation after the first 24 hours after completion of procedure. ]Use of pain-relieving drugs 24h postpartum; type and amount of drugs for pain relief will be recorded for the first 24 hours after completion of procedure.
- Patient experience [ Time Frame: On Day 1 after randomization. Evaluates 24 hours after completion of procedure or upon discharge from hospital. Evalutation after 24 hours. ]
Patient experience (at 24h postpartum or just before discharge from hospital with the same questions as asked directly after the procedure (OAA/S 5):
Pain; measured with a VAS-scale (0-100 mm, "No pain" to "Worst imaginable pain").
Discomfort; measured with a VAS-scale (0-100 mm, "No discomfort" to "Worst imaginable discomfort").
Anxiety; measured with a VAS-scale (0-100 mm, "No anxiety" to "Worst imaginable anxiety").
- Peripheral capillary oxygen saturation [ Time Frame: After randomization, From time to event. Recorded every five minutes during the procedure by monitoring oxygen saturation. ]Will be recorded Patient monitor Philips Intellivue MX700 and IntelliVue X3.
- Respiratory frequency [ Time Frame: After randomization,From time to event. Recorded every five minutes during the procedure by monitor Philips Intellivue MX700 and InterlliVueX3. ]Will be recorded Patient monitor Philips Intellivue MX700 and IntelliVue X3.
- Non-invasive blood pressure [ Time Frame: After randomization,From time to event. Recorded every five minutes during the procedure with monitor Philips Intellivue MX700 and IntelliVue X3. ]Will be recorded Patient monitor Philips Intellivue MX700 and IntelliVue X3.
- Heart rate [ Time Frame: After randomization,From time to event. Recorded every five minutes during the procedure with monitor Philips Intellivue MX700 and IntelliVue X3. ]Will be recorded Patient monitor Philips Intellivue MX700 and IntelliVue X3.
- Level of sedation [ Time Frame: After randomization,From time to event. Recorded every five minutes during the procedure ]Level of sedation; is assessed by the midwife using The Observer's Assessment of Alertness/Sedation (OAA/S) scale. The scoring of OAA/S scale specifying sedation level score between "Does not respond to mild prodding or shaking" (score 1) to "Responds readily to name spoken in normal tone" (score 5). Level of sedation is measured by the midwife in 5 minutes intervals until procedure completion.
- Interventions [ Time Frame: After randomization,From time of randomization to end of procedure with PNB or PNB+PCS. ]Interventions performed to maintain cardiovascular and respiratory stability; according to the pre-defined safety limits will be recorded.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Females after labor |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patient (≥18 years)
- Planned examination and repair of perineal laceration
- The patient has after receiving verbal and written information about the study given her signed informed consent to participate
Exclusion Criteria:
- Perineal laceration grade III-IV
- BMI > 35 (during first visit at the maternity care centre)
- Deviation from department guidlines regarding preopartive fasting
- Preeclampsia or hypertensive disease
- Postpartum haemorrhage > 1000 ml
- Known/suspected allergy or contraindication to any medication within the study
- Functional disability in both hands which affect the possibility to operate the PCS device
- Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044103
Contact: Linda Hjertberg, MD | +4610-104 26 03 | linda.hjertberg@regionostergotland.se | |
Contact: Benjamin Grossmann, PhD | benjamin.grossmann@regionostergotland.se |
Sweden | |
Vrinnevihospital | Recruiting |
Norrköping, Sweden | |
Contact: Linda Hjertberg, MD |
Principal Investigator: | Linda Hjertberg, MD | Department of Obstetrics and Gynecology, Vrinnevi Hospital, Sweden. |
Responsible Party: | Marie Blomberg, Professor in Obstetrics and Gyneacology, Linkoeping University |
ClinicalTrials.gov Identifier: | NCT06044103 |
Other Study ID Numbers: |
PROP(ofol) 2022-502292-39 ( EudraCT Number ) |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | All IPD that underlie results in a publication will be available for sharing on request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | The supporting information will be available from november 2025 until 6 months after publication |
Access Criteria: | Requests for sharing IPD that underlie results in a publication can be made to the principal investigator. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
obstetric perineal lacerations patient-controlled sedation propofol |
Lacerations Wounds and Injuries |