Clinical trial NCT04153396: Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy
Official title: Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Neurosurgery
Keywords: Pain, Postoperative
Betamethasone;
Ropivacaine;
Wound Infiltration
Laminoplasty or Laminectomy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. However, current methods of pain control are mostly insufficient. At present, several pain controlling methods are available, to reduce postoperative pain after laminoplasty or laminectomy. Methods for systemic administration include: oral analgesics, intermittent intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc. However, the aforementioned methods may have a lot of side effects, and are usually used after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical administration options use a lower dose of drugs and therefore have less systemic side effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. It is necessary to use more cases to explore the other compatibility of drugs with longer duration of action and stronger analgesic effect. Betamethasone as the stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting anti-inflammatory properties. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled, blinded-endpoint study is needed to compare the postoperative analgesic efficacy of preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for laminectomy or laminoplasty.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery under general anaesthesia for laminectomy or laminoplasty;
* American Society of Anaesthesiologists (ASA) classification of I or II;
* Age 18 to 64 years;
* Participates with an anticipated full recovery within 2 hours postoperatively.

Exclusion Criteria:

* Patient refusal;
* Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS);
* Previous history of spinal surgery;
* Allergy to opioids, betamethasone or ropivacaine;
* Peri-incisional infection;
* History of stroke or a major neurological deficit;
* Trauma, deformity;
* Psychological problems;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* Patients using systemic steroids;
* Pregnant or breastfeeding;
* Preoperative Glasgow Coma Scale \< 15;
* Participants who have received radiation therapy or chemotherapy preoperatively, or with a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging.
* Not able to give written informed consent

Primary outcomes:
measure: The cumulative butorphanol dose during the 48 hours after surgery via the PCA device.
timeFrame: Within 48 hours after the operation
Secondary outcomes:
measure: The Visual Analogue Scale (VAS) during movement (VASm)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
measure: The Visual Analogue Scale (VAS) at rest (VASr)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
measure: The total times that participants press patient-controlled analgesia button
timeFrame: Within 48 hours after the operation
measure: The first analgesia demand on the PCA device
timeFrame: Within 48 hours postoperatively
measure: Patient Satisfaction Score (PSS)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 4 weeks, 6 weeks, 3 months and 6 months after surgery
measure: The Postoperative Nausea and Vomiting (PONV)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: Ramsay Sedation Scale (RSS)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
measure: The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores
timeFrame: At 6 months postoperatively
measure: The Oswestry Disability Index (ODI)
timeFrame: Preoperatively and at 4 weeks, 6 weeks and 3 months, 6 months after surgery.
measure: Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
timeFrame: At 6 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Itoh T, Tsuji H. Technical improvements and results of laminoplasty for compressive myelopathy in the cervical spine. Spine (Phila Pa 1976). 1985 Oct;10(8):729-36. doi: 10.1097/00007632-198510000-00007.
citation: Takayasu M, Takagi T, Nishizawa T, Osuka K, Nakajima T, Yoshida J. Bilateral open-door cervical expansive laminoplasty with hydroxyapatite spacers and titanium screws. J Neurosurg. 2002 Jan;96(1 Suppl):22-8. doi: 10.3171/spi.2002.96.1.0022.
citation: Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T. Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014;24(1):48-53. doi: 10.5137/1019-5149.JTN.8431-13.0.
citation: Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. doi: 10.1097/01.brs.0000232801.19965.a0.
citation: Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
citation: Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.
citation: Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.
citation: Shrestha N, Wu L, Wang X, Jia W, Luo F. Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial. Trials. 2020 May 5;21(1):381. doi: 10.1186/s13063-020-04308-z.