The Effect of Ultra–low-dose Intrathecal Naloxone on Pain Intensity After Lumbar Laminectomy With Spinal Fusion: A Randomized Controlled Trial

Abstract

Background: Despite advances in pain management, several patients continue to experience severe acute pain after lumbar spine surgery. The aim of this study was to assess the safety and effectiveness of single ultra–low-dose intrathecal (IT) naloxone in combination with IT morphine for reducing pain intensity, pruritus, nausea, and vomiting in patients undergoing lumbar laminectomy with spinal fusion. Materials and Methods: In this double-blind trial, patients scheduled for lumbar laminectomy with spinal fusion were randomly assigned to receive single ultra–low-dose IT naloxone (20 μg) and IT morphine (0.2 mg) (group M+N) or IT morphine (0.2 mg) alone (group M). The severity of postoperative pain, pruritus and nausea, and frequency of vomiting were assessed at recovery from anesthesia and, subsequently, at 1, 3, 6, 12, and 24 hours postoperatively using an 11-point (0-10) visual analogue scale. Results: A total of 77 patients completed the study, and there were significant differences in postoperative pain, pruritus, and nausea visual analogue scale between the groups (P<0.05). After adjusting for body mass index and surgery duration, IT naloxone administration reduced the pain score (coefficient=1.84; 95% confidence interval [CI], 1.05-2.63; P<0.001), and the scores of pruritus and nausea (coefficient=0.9; 95% CI, 0.44-1.37; P<0.001 and coefficient=0.71; 95% CI, 0.12-1.31; P=0.02, respectively) compared with IT morphine alone. No serious adverse effects were observed. Conclusions: The addition of ultra–low-dose IT naloxone to IT morphine provides excellent postoperative pain management and effectively controls pruritus and nausea in patients undergoing laminectomy with spinal fusion.

Pain management after laminectomy: a systematic review and procedure-specific post-operative pain management (prospect) recommendations

“…Although the studies did not describe infiltration techniques, it is well accepted that any surgical site infiltration should involve local anaesthetic injection into multiple layers, similar to local infiltration techniques used for joint surgery. Intrathecal opioids have been demonstrated to provide excellent pain relief in patients undergoing lumbar laminectomy [30,32]. However, the potential side effects are worrisome, particularly because this procedure is increasingly being performed as an outpatient procedure [2,3].…”

“…Firouzian et al compared the intrathecal morphine 200 µg to the combination of intrathecal morphine 200 µg and naloxone 20 µg [32]. Rescue analgesia included IV-PCA morphine.…”

Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS®) Society recommendations

“…However, the incidence of pruritus appears to be higher [167,168]. The addition of naloxone may facilitate the efficacy of intrathecal morphine injection and reduce complications (eg, pruritus and nausea) [169]. Even for minimally invasive surgery, intrathecal morphine injection reduces postoperative pain and patientcontrolled analgesia (PCA) morphine consumption [170].…”

Enhanced recovery after surgery (ERAS) protocol in spine surgery

“…47 The combination of naloxone and morphine for intrathecal use has been shown to further increase efficacy and reduce complications compared to intrathecal morphine alone. 48 Besides morphine the intrathecal use of fentanyl has also been shown to be effective in decreasing pain and opioid requirements with minimal respiratory depression requiring no intervention. 49 Epidural analgesia (EA) using long acting local anaesthetics with or without opioids have also been shown to be effective in reducing postoperative pain and decreasing opioid requirement.…”