Clinical trial NCT06659965: Intravenous Methocarbamol for Acute Pain After Spine Surgery
Official title: Intravenous Methocarbamol for Acute Pain After Spine Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Post Operative Pain
Postsurgical Pain Management
Spine Surgery
Acute Pain, Postoperative
Multimodal Analgesia
Keywords: methocarbamol
postoperative pain
Robaxin
spine surgery
acute postsurgical pain
postsurgical pain
target trial emulation
postoperative analgesia
postoperative pain management
multimodal pain management
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-10-26
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of adult patients undergoing elective spine surgeries at multiple hospitals within a large health system in Houston, TX. This includes individuals receiving surgical interventions for conditions such as degenerative disc disease, spinal stenosis, or other spinal pathologies that require procedures like ACDF, posterior spinal fusion, or laminectomy. Participants will be selected from those who receive perioperative care across various hospital settings within the health system, including postoperative management in the Post-Anesthesia Care Unit (PACU).

Brief summary: The goal of this target trial emulation is to evaluate the impact of intravenous (IV) methocarbamol on postoperative pain and opioid use in adults undergoing elective spine surgery. The main questions it aims to answer are:

* Does IV methocarbamol reduce pain in the 6 hours following surgery?
* Does IV methocarbamol decrease the need for opioid pain medications in the same period?

Participants who receive IV methocarbamol as part of their routine postoperative care will have their pain scores and opioid consumption tracked for 6 hours after treatment. Pain levels will be measured using standard assessments, and opioid use will be quantified in oral morphine equivalents.

Detailed description: The IMAPSS study is a target trial emulation evaluating the effect of intravenous (IV) methocarbamol on postoperative pain management and opioid consumption in adult patients undergoing elective spine surgery. The study employs a target trial emulation design to simulate the conditions of a randomized controlled trial using observational data extracted from electronic medical records. The main focus is to determine if administering IV methocarbamol within two hours after surgery reduces postoperative pain scores and opioid use.

Patients will be tracked from the point of their first recorded pain score in the Post-Anesthesia Care Unit (PACU) after surgery to assess for treatment assignment eligibility. Data will be collected at 15-minute intervals, which corresponds to the standard assessment frequency in Phase I PACU care, for up to 12 hours postoperatively for each patient. The primary analysis will use time-varying propensity score matching (TV-PSM) to control for baseline and time-varying confounders. Pain levels will be measured using a time-weighted average (TWA) of pain scores, and opioid consumption will be quantified in oral morphine equivalents (OME).

The primary analysis will utilize TV-PSM, with propensity scores estimated through a Cox proportional hazards model. Matching will create balanced treatment groups at each 15-minute interval. Generalized estimating equations (GEE) will then estimate the effect of IV methocarbamol on the primary outcome (TWA pain) and secondary outcome (cumulative OME) over a 6-hour postoperative period. As a sensitivity analysis, a marginal structural model (MSM) using inverse probability weighting (IPW) will assess the robustness of the findings to the time-varying confounder adjustment.

This study's findings will aim to inform evidence-based recommendations for postoperative pain management and opioid-sparing strategies, potentially providing safer alternatives to conventional opioid-based regimens.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Undergoing one of the following three elective spine surgeries: (i) Anterior Cervical Discectomy and Fusion (ACDF), (ii) Posterior Spinal Fusion, or (iii) Laminectomy, Laminotomy, or Discectomy
* At least 8h of valid pain scores recorded postoperatively

Exclusion Criteria:

* Emergency Surgery
* Pregnancy
* Sensitivity to methocarbamol (allergy)
* End-stage renal disease (ESRD)
* Myasthenia gravis
* Missing a valid electronic anesthesia record

Primary outcomes:
measure: Time-Weighted Average Pain Score
timeFrame: 6 hours after treatment assignment
Secondary outcomes:
measure: Cumulative Opioid Use
timeFrame: 6 hours after treatment assignment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Health System
state: Texas
Study officials:
References: