Fixed-Interval vs. On-Demand Analgesia After Vacuum-Assisted Delivery: RCT

Fixed-time Interval vs. On-demand Analgesia Following Vacuum-assisted Vaginal Delivery: A Randomized Controlled Trial

This randomized controlled trial evaluates the effectiveness of scheduled versus on-demand pain relief protocols in managing postpartum pain during the first 24 hours after vacuum-assisted delivery.

Objectives:

Primary: Compare pain reduction (VAS scores) between the two protocols. Secondary: Assess extended pain relief use, breastfeeding rates, maternal satisfaction, and postpartum hospitalization duration.

Design:

Participants: 200 women aged 18-45, randomized into two groups:

Scheduled Pain Relief: Acetaminophen and diclofenac every 8 hours. On-Demand Pain Relief: Same medications administered upon request. Pain levels are assessed via VAS every 8 hours and around medication times. All participants receive IV acetaminophen immediately postpartum and additional pain relief for breakthrough pain as needed.

Data Collection: Demographics, delivery details, pain scores, medication use, breastfeeding rates, and satisfaction (using the Birth Satisfaction Scale-BSS-R) will be recorded.

Significance: The study aims to fill a gap in the literature on postpartum pain management for vacuum-assisted deliveries, improving care and maternal outcomes.

Study Overview

• Status: Completed
• Conditions: Vacuum-assisted Deliveries
• Intervention / Treatment: Drug: Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.; Other: On demand analgesia

Detailed Description

Study Objectives:

1. Primary Objective: Compare the effectiveness of scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum, using the VAS (Visual Analog Scale) for pain (1-10).

2. Secondary Objectives:

   • Measure VAS scores every 8 hours during the first 24 hours postpartum.
   • Assess the use of pain relief beyond 24 hours postpartum, including the use of morphine.
   • Evaluate breastfeeding rates, satisfaction with the birth experience, and length of postpartum hospitalization.

Study Design:

• Recruitment: Women will be recruited immediately after vacuum-assisted delivery.
• Participants will provide informed consent and be assigned a unique anonymous identifier for data collection.
• All participants will receive 1,000 mg of IV acetaminophen immediately postpartum, per departmental protocol.

• Participants will be randomized (1:1) into two groups:

  1. Scheduled Pain Relief Group: Oral acetaminophen (1 g) and diclofenac (50 mg) every 8 hours for the first 24 hours postpartum.
  2. On-Demand Pain Relief Group: The same oral medications as the scheduled group but administered only upon request.
• After the first 24 hours postpartum, both groups will receive pain relief on-demand.
• Women experiencing breakthrough pain despite their assigned protocol will receive additional medication as needed, and such interventions will be recorded.

Pain Assessment:

Pain levels will be assessed using the VAS scale every 8 hours, and one hour before and after administering pain relief.

Data Collection:

• Demographics: Age, BMI, parity, gestational age at delivery.

• Delivery details:

  • Mode of labor onset (spontaneous or induced).
  • Cervical ripening method (prostaglandins or balloon).
  • Use of oxytocin during labor.
  • Duration of active and second stages of labor.
  • Use of epidural anesthesia.
  • Perineal tears (grades 1-4).
  • Estimated and excessive blood loss.
  • Placental separation (manual removal or uterine exploration).
  • Neonatal weight.

• Outcomes:

  • Pain scores (VAS)
  • Medication use
  • Breastfeeding rates
  • Birth satisfaction (assessed via the validated Birth Satisfaction Scale-BSS-R).

Study Population:

• Inclusion Criteria: Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.

• Exclusion Criteria:

  1. Allergy to acetaminophen or NSAIDs.
  2. Chronic pain conditions (e.g., endometriosis, fibromyalgia).
  3. Cesarean deliveries.
  4. Multiple pregnancies.

Sample Size:

Based on prior studies, 100 women per group are required to detect a 33% reduction in VAS scores (from 6 ± 2 to 4 ± 2) with 80% power and a 5% significance level. A total of 200 participants will be recruited.

Duration:

The study will run for five years. Data will be securely stored for 15 years in a locked cabinet and password-protected computer accessible only to the principal investigator.

Statistical Analysis:

Data will be analyzed using SPSS software. ANOVA will be used to compare outcomes between groups.

This study addresses a gap in literature by investigating pain management protocols specifically for vacuum-assisted deliveries, aiming to improve postpartum care and maternal satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 4861027
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.

Exclusion Criteria:

1. Allergy to acetaminophen or NSAIDs.
2. Chronic pain conditions (e.g., endometriosis, fibromyalgia).
3. Cesarean deliveries.
4. Multiple pregnancies.
5. Normal vaginal delivery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scheduled Pain Relief	Drug: Scheduled Pain relief drugs administered during the first 24 hours postpartum every 8 hours.; Oral acetaminophen (1 g) and diclofenac (50 mg) administered during the first 24 hours postpartum together every 8 houers; Other Names: Scheduled
Placebo Comparator: On-Demand Pain Relief Group; pain relief drug by request	Other: On demand analgesia; Administration of analgesics upon patient request; Other Names: On demand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum	Compare the effectiveness of scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum, using the VAS (Visual Analog Scale) for pain (1-10).	From enrollment until discharge following delivery, up to 1 week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relif use, hospitalization, breastfeeding and maternal satisfaction.	group differences in VAS pain scores at predefined 8-hour intervals during the first 24 hours postpartum, use of additional analgesia beyond 24 hours postpartum, breastfeeding rates, length of postpartum hospitalization and maternal satisfaction.	From enrollment until discharge following delivery, up to 1 week.
Baseline maternal and obstetric characteristics	Maternal age (Years), body mass index (BMI), parity, and gestational age at delivery. (weeks)	From enrollment until discharge following delivery, up to 1 week.
Labor and delivery characteristics	mode of labor onset, cervical ripening method (prostaglandins, balloon catheter, or combined methods), use of oxytocin augmentation, epidural anesthesia, and indication for vacuum-assisted delivery (non-reassuring fetal heart rate, prolonged second stage, or maternal exhaustion)	From enrollment until discharge following delivery, up to 1 week.
Delivery outcomes and maternal complications	Episiotomy, degree of perineal lacerations (1-4 degree), postpartum hemorrhage, maternal fever, manual removal of the placenta, uterine revision, urinary retention, retained products of conception.	From enrollment until discharge following delivery, up to 1 week.

Collaborators and Investigators

• Sponsor: Yael Yagur
• Collaborators: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2024
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: vacuum-assisted deliveries; Pain managmant after vacuum
• Additional Relevant MeSH Terms: Organization and Administration; Health Services Administration; Surgical Procedures, Operative; Obstetric Surgical Procedures; Abortion, Induced; Appointments and Schedules; Abortion, Legal
• Other Study ID Numbers: 104-24MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No