Project description:ObjectivesTo evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components.Design and settingA feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.ParticipantsConsecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.InterventionsParticipants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Main outcome measuresBlinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.ResultsAt discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported.ConclusionsBoth interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome.Trial registrationISRCTN registry 33808269.

Project description:BackgroundSpinal surgery can be associated with significant postoperative pain. Erector spinae plane (ESP) block is a new regional anaesthesia technique, which promises effective postoperative analgesia compared with systemically administered opioids, but has never been evaluated in terms of patient-centred outcomes such as quality of recovery and overall morbidity after major thoraco-lumbar spinal surgery.MethodsWe are conducting a prospective, randomised, double-blind trial in two hospitals in the Republic of Ireland. The sample size will be 50 patients (25 in the intervention group and 25 in the control group). Randomisation will be done using computer-generated concealed envelopes. Both patients and investigators collecting outcome data will be masked to group allocation. Participants will be male or female, aged 18 years and over, capable of providing informed consent and ASA grade I-IV. Patients scheduled to undergo posterior approach thoraco-lumbar decompression surgery involving 2 or more levels will be recruited to the study. Participants randomised to the intervention arm of the study will receive bilateral ultrasound-guided ESP block totalling 40 ml 0.25% levo-bupivcaine (20 ml each side), post induction of general anaesthesia and before surgical incision. The control group will not receive an ESP block. Both groups will receive the same standardised analgesic protocol both intra- and postoperatively. The primary outcome will be the quality of recovery at 24 h postoperatively as determined by the QoR-15 score. This score is determined by a questionnaire which measures patient responses to 15 subjective parameters, each response graded on a scale from 0 to 10. The maximum score achievable is 150 with a potential minimum score of 0. Higher scores indicate a higher quality of recovery experience. Secondary outcomes will include area under the curve (AUC) of VRS pain versus time at rest and on movement up to 24 h postoperatively, 24 h opioid consumption, time to first analgesia in recovery, length of stay (LOS), incidence and severity of postoperative complications as measured by the Comprehensive Complication Index (CCI) score.DiscussionTo the best of our knowledge, this will be the first randomised control trial to examine the efficacy and safety of the ESP block in terms of patient-centred outcomes in the setting of major spinal surgery. The QoR-15 is a validated means of assessing the quality of recovery after surgery and gives a more holistic assessment of the recovery experience from the patient's point of view.Trial registrationThis trial is pre-registered on ClinicalTrials.gov reference number NCT04370951 . Registered on 30 April 2020. All items from the World Health Organisation Trial Registration Data Set have been included.

Project description:BackgroundThoracolumbar intervertebral disc extrusion is a common neurologic complaint in dogs and is associated with debilitating pain that requires careful analgesic management to avoid the transition to a chronic pain state. Recently, there has been an increased effort to incorporate regional anaesthetic techniques whenever possible, both for perioperative analgesia management and for prevention of chronic pain. A novel regional anaesthetic technique named retrolaminar block is a fascial plane block where the local anaesthetic is injected directly on top of the dorsal aspect of the vertebral lamina, in the fascial plane between the lamina and the epaxial muscles. The technique was recently described in humans and it is claimed to provide analgesia in patients undergoing thoracic and lumbar procedures. To the authors' knowledge, the retrolaminar block has not been previously reported in live dogs.Case presentationSeven dogs presented to our hospital for suspected thoracolumbar intervertebral disc extrusion were anaesthetised using an anaesthetic premedication and induction protocol tailored for each individual animal. Once the suspected diagnosis was confirmed, all seven dogs were placed in sternal recumbency, and the target thoracolumbar vertebral spinous process was identified with palpation. A unilateral retrolaminar block was performed in all dogs with 2 mg/kg of 0.25% bupivacaine. Physiologic parameters, as well as responses to nociceptive stimuli, were monitored throughout the anaesthetic event. Intraoperatively, one dog required a bolus of fentanyl to control nociceptive stimulation while the epaxial muscles were retracted. No further intraoperative rescue analgesia was required in any of the cases. The postoperative pain was assessed using the Short Form of Glasgow Composite Measure Pain Scale for dogs every four hours for the duration of the dogs' hospitalization. The retrolaminar block reduced the intraoperative requirement for systemic opioids and other adjunct analgesic agents and all dogs were comfortable throughout their hospitalization and up until the time of their discharge.ConclusionsThis case report presents the performance of the retrolaminar block technique as part of multimodal analgesia management in seven dogs undergoing thoracolumbar spinal surgery.

Project description:This was a retrospective study. The present study investigates whether Percutaneous Endoscopic Lumbar Discectomy via Transforaminal Approach Combined with Interlaminar Approach(PELD) is no less effective than posterior lumbar interbody fusion(PLIF) in the treatment of L4/5 and L5/S1 two-level disc herniation. In this retrospective study, we included 40 patients with L4/5 and L5/S1 two-level lumbar disc herniation (LDH) who received PELD (n = 18) or PLIF (n = 22). The two groups are divided into a united group(PELD) and a fusion group(PLIF). In the united group, the transforaminal approach was adopted for L4/5 level disc herniation, and the interlaminar approach was adopted for L5/S1 level disc herniation. The degree of nerve root and dural compression determined by MRI was taken preoperatively. The clinical outcomes which preoperative 1 week, 3 months,6 months,12 months, 24 months, 36months and final follow-up after surgery between the two groups were evaluated using the visual analog scale (VAS), the Oswestry disability index (ODI), the Japanese Orthopaedic Association (JOA) and the modified MacNab criteria. In both groups, the VAS, ODI and JOA scores at different timepoints postoperatively were significantly improved compared with those preoperatively (P < 0.05). According to the modified MacNab criteria, the excellent or good outcome rate was 94.44% in the united group and 90.91% in the fusion group. Within 1 week after the operation, there was a significant difference in the improvement of clinical symptoms between the combination group and the fusion group (P < 0.05), and the combination group was better than the fusion group. Additionally, within three months postoperatively, the combination group exhibited significantly better functional improvements compared to the fusion group .With the gradual recovery of patients, there was no significant difference in the improvement of clinical symptoms between the two groups (P > 0.05). To sum up, This study aimed to compare the efficacy of PELD and PLIF in the treatment of dual-segmental lumbar disc herniation of L4/5 and L5/S1. Compared with PLIF, PELD has advantages in less intraoperative bleeding, shorter operation time and non-general anesthesia. However, the possibility of postoperative recurrence of PLIF is lower. In short, both methods can bring satisfactory results to patients. Clinically, surgeons should carefully weigh the advantages and disadvantages of the two operations and choose the operation method suitable for patients. At the same time, in future studies, we should further extend the follow-up time to observe whether vertebral fusion has more advantages in preventing postoperative recurrence.

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Retrolaminar block for opioid-free anaesthesia and enhanced recovery after posterior lumbar discectomy: A randomised controlled study

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