Intravenous Methocarbamol for Acute Pain After Spine Surgery
NCT ID: NCT06659965
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1270 participants
OBSERVATIONAL
2020-01-01
2025-06-30
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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IV methocarbamol
Patients who received intravenous methocarbamol
Intravenous Methocarbamol
At least 500 mg of intravenous methocarbamol administered within 2 hours after the end of elective spine surgery for acute postoperative pain management
Usual Care
Patients who received usual postoperative pain management after surgery without any intravenous methocarbamol administration
No interventions assigned to this group
Interventions
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Intravenous Methocarbamol
At least 500 mg of intravenous methocarbamol administered within 2 hours after the end of elective spine surgery for acute postoperative pain management
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Sensitivity to methocarbamol (allergy)
* End-stage renal disease (ESRD)
* Myasthenia gravis
* Missing a valid electronic anesthesia record
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Paul Potnuru
Associate Professor
Principal Investigators
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Paul Potnuru, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Health System
Houston, Texas, United States
Countries
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References
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Potnuru P, Baranov A, Khudirat M, Turan A. Intravenous methocarbamol for acute pain after spine surgery: a target trial emulation. Reg Anesth Pain Med. 2025 Sep 8:rapm-2025-107010. doi: 10.1136/rapm-2025-107010. Online ahead of print.
Other Identifiers
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HSC-MS-24-1095
Identifier Type: -
Identifier Source: org_study_id