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

Overview

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.