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 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.

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.