Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial

Abstract

Objectives: We aimed to determine whether regional analgesia with intrathecal morphine (ITM) in an enhanced recovery programme (enhanced recovery after surgery [ERAS]) gives a shorter hospital stay with good pain relief and equal health-related quality of life (QoL) to epidural analgesia (EDA) in women after midline laparotomy for proven or assumed gynaecological malignancies.

Design: An open-label, randomised, single-centre study.

Setting: A tertiary referral Swedish university hospital.

Participants: Eighty women, 18-70 years of age, American Society of Anesthesiologists I and II, admitted consecutively to the department of Obstetrics and Gynaecology.

Interventions: The women were allocated (1:1) to either the standard analgesic method at the clinic (EDA) or the experimental treatment (ITM). An ERAS protocol with standardised perioperative routines and standardised general anaesthesia were applied. The EDA or ITM started immediately preoperatively. The ITM group received morphine, clonidine and bupivacaine intrathecally; the EDA group had an epidural infusion of bupivacaine, adrenalin and fentanyl.

Primary and secondary outcome measures: Primary endpoint was length of hospital stay (LOS). Secondary endpoints were QoL and pain assessments.

Results: LOS was statistically significantly shorter for the ITM group compared with the EDA group (median [IQR]3.3 [1.5-56.3] vs 4.3 [2.2-43.2] days; p=0.01). No differences were observed in pain assessment or QoL. The ITM group used postoperatively the first week significantly less opioids than the EDA group (median (IQR) 20 mg (14-35 mg) vs 81 mg (67-101 mg); p<0.0001). No serious adverse events were attributed to ITM or EDA.

Conclusions: Compared with EDA, ITM is simpler to administer and manage, is associated with shorter hospital stay and reduces opioid consumption postoperatively with an equally good QoL. ITM is effective as postoperative analgesia in gynaecological cancer surgery.

Trial registration number: NCT02026687; Results.

Keywords: gynecological malignancy; laparotomy; opioid consumption; quality improvement; regional analgesia.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

CONSORT flow chart of participants in the study. EDA, epidural analgesia; ITM, intrathecal morphine analgesia.

Figure 2

Illustration of the EuroQol 5-dimension (EQ-5D) weighted health state index in relation to occasion of measurement. Plots represent means and bars represent 95% CI. Result of the repeated measures analysis of variance (ANOVA) from day 0–42 assessment is presented. No significant differences were observed in the EQ-5D health index between the two groups preoperatively. EDA, epidural analgesia; ITM, intrathecal morphine analgesia.

Figure 3

Assessment of pain by means of a 10 graded numeric rating scale (NRS) at rest and at mobilisation. Plots represent means and bars represent 95% CI. Results of the repeated measures analysis of variance (ANOVA) and post hoc tests from day 0 to the day 6 are shown in the table below the diagrams. Assessments done from the evening of surgery and three times daily. Days 1.1, 1.2 and 1.3, respectively, represent the measurements performed in the morning, the afternoon and the evening on day 1. EDA, epidural analgesia; ITM, intrathecal morphine analgesia.

Figure 4

Consumption of analgesics after surgery in relation to occasion of measurement. Plots represent means and bars represent 95% CI. Results of the repeated measures analysis of variance (ANOVA) and post hoc tests from day 0 to the day 6 assessment for equivalent morphine given and for day 3 to day 42 for defined daily dose (DDD) non-opioids are presented in the table below the diagram. EDA, epidural analgesia; ITM, intrathecal morphine analgesia.