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The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1067 - 1072
1 Sep 2022
Helenius L Gerdhem P Ahonen M Syvänen J Jalkanen J Charalampidis A Nietosvaara Y Helenius I

Aims. The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption. Methods. Adolescents (aged between 10 and 21 years) with an idiopathic scoliosis (major curve ≥ 45°) were eligible for inclusion in this randomized controlled noninferiority trial (n = 125). A total of 90 adolescents who had undergone segmental pedicle screw instrumentation were randomized into no-drain or drain groups at the time of wound closure using the sealed envelope technique (1:1). The primary outcome was a drop in the haemoglobin level during first three postoperative days. Secondary outcomes were 48-hour postoperative oxycodone consumption and surgical complications. Results. All 90 patients were included in the primary outcome analysis (no drain = 43; drain = 47). The mean total postoperative blood loss (intraoperative and drain output) was significantly higher in the group with a subfascial drain than in the no-drain group (1,008 ml (SD 520) vs 631 ml (SD 518); p < 0.001). The drop in haemoglobin level did not differ between the study groups over the postoperative timepoints (p = 0.290). The 48-hour opioid consumption was significantly higher in the no-drain group (2.0 mg/kg (SD 0.9) vs 1.4 (SD 0.6); p = 0.005). Two patients in the no-drain and one patient in the drain group developed a surgical site infection. Conclusion. Leaving the subfascial drain out after pedicle screw instrumentation for AIS is not associated with higher postoperative haemoglobin levels. Patients treated without a subfascial drain needed 30% more opioids during the first 48 hours than those who had a drain. Cite this article: Bone Joint J 2022;104-B(9):1067–1072


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1176 - 1181
1 Oct 2024
Helenius L Gerdhem P Ahonen M Syvänen J Jalkanen J Nietosvaara Y Helenius I

Aims. Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported. Methods. We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a ‘drain’ or ‘no drain’ group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up. Results. As previously reported, the mean 48-hour opioid consumption was significantly higher in the no drain group (2.0 mg/kg (SD 0.8) vs 1.4 mg/kg (SD 0.7); p = 0.005). There were no delayed deep SSIs. At two years’ follow-up, the mean Scoliosis Research Society 24-item questionnaire (SRS-24) total score did not differ between the groups (4.11 (SD 0.47) vs 4.16 (SD 0.33); p = 0.910). The mean SRS-24 pain score was 4.28 (SD 0.48) in the no drain group compared with 4.33 (SD 0.66) in the drain group (p = 0.245). Seven patients (19%) in the no drain group and six in the drain group (14%) reported moderate to severe pain (numerical rating scale ≥ 4) at two years’ follow-up (p = 0.484). The general self-image domain score was significantly higher in the no drain group compared with the drain group (4.02 (SD 0.74) vs 4.59 (SD 0.54); p < 0.001). Conclusion. The main finding in this study was that more severe pain immediately after surgery did not result in a higher incidence of chronic pain in the no drain group compared with the drain group. Back pain and health-related quality of life at two years’ follow-up did not differ between the groups. The patient-reported self-image domain was significantly better in the no drain group compared with the drain group. Cite this article: Bone Joint J 2024;106-B(10):1176–1181


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 37 - 37
7 Aug 2024
Wilson M Cole A Hewson D Hind D Hawksworth O Hyslop M Keetharuth A Macfarlane A Martin B McLeod G Rombach I Swaby L Tripathi S Wilby M
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Background. Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. Methods. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios. Results. Differences in the primary outcome at 24 hours will be estimated by mixed-effects linear regression modelling, with fixed effects for randomisation factors and other important prognostic variables, and random effects for centre, using the as-randomised population. Treatment effects with 95% confidence intervals will be presented. Conclusion. The study is due to open in May 2024 and complete in 2026. Conflicts of Interest. No conflicts of interest declared. Sources of Funding. NIHR Health Technology Award – grant number NIHR153170. Trial presentations so far. APOMP 2023 and 2024; RCOA conference, York, November 2023; Faculty of Pain Management training day, London, February 2024