Post-Operative Pain After Pelvic Organ Prolapse Surgery (POPPOP): A Double Blind Randomised Multicentre Study to Assess the Effect of Local Anaesthesia During Vaginal Hysterectomy

Abstract

Objective: To compare local anaesthetic with adrenaline (LAA) with normal saline for hydrodissection at vaginal hysterectomy. Design: A double-blind, two parallel group multicentre randomised controlled trial (RCT) was planned. Setting: 217 women undergoing vaginal hysterectomy were screened in the five participating centres between March 2015 and December 2018. Population: 156 patients were recruited. Methods: Patients were randomised to Bupivacaine 0.25%/0.5% with adrenaline 1:200000 vesus normal saline. They completed baseline ‘pre-operation’, ‘same day 3–6 h post-op’ and ‘morning after surgery’ short-form McGill pain questionnaire (SFMcGill). Main Outcome Measures: Primary endpoint was post-operative pain measured using SFMcGill. Secondary endpoints included estimated blood loss (EBL), ease of dissection, severity of ooze, change in pre- and post-operative haemoglobin, operating time, duration of inpatient stay and incidence of post-operative morbidity. Results: There were no demographic differences between the groups. LAA was associated with significantly smaller increases in pain scores compared to placebo, both between pre-operative and same-day post-operative (7.105 p < 0.001) and to the next day post-operative (1.334 p < 0.001). Use of placebo infiltrate was associated with increased intra-operative bleeding (difference in EBL 110 mL p < 0.001), increased severity of ooze (VAS difference 5.01 p < 0.001), and more difficult dissection (VAS difference 2.96 p < 0.001). There were no differences in pre-operative or post-operative measures of Hb, PCV, or post-operative analgesia (p > 0.05). There were significantly more complications in the placebo arm (5 vs. 0, p = 0.02). Conclusions: This multicentre-RCT demonstrated the value of LAA compared to normal saline as a paracervical infiltrate during vaginal hysterectomy under general anaesthesia: reduced intra-operative blood loss, improved ease of dissection, decreased same and next day pain scores and complications.