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NCT Number: NCT01902108

Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine

The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.

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Key information

Conditions

Post-operative Pain Ankylosis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu de france Hospital

Beirut, 16-6830, Lebanon

About this study

Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. After verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150 μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and other pre and per operative medical data are noted. In the post-operative period, patients received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8 after surgery. Morphine rescue consumption is noted. Finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First (not recurrent) posterior spinal surgery at the operated site
  • American Society of Anesthesiologists class I or II (operative risk)

Exclusion criteria

  • Allergy to local anesthetics or to clonidine
  • Pregnancy
  • Raynaud's syndrome
  • Thromboangiitis obliterans
  • History of substance abuse
  • Current treatment with corticosteroids

Treatment and study plan

Bupivacaine

Drug

Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone

Clonidine

Drug

Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Primary outcomes

  1. Mean Area under curve

    Time frame: From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h

    Pain is assessed on numeric rating scale (NRS) 8times/day during the first 3 days, 3times/day during the next 6days and one mean value during the night. The mean intensity of daily pain is obtained from the different values mentioned during day and night corrected by the duration covered by every value. It may vary from 0 to 10.

Secondary outcomes

  1. Area under Curve (AUC) of pain

    Time frame: Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8

    The AUC during an interval (in days) is calculated by adding the different values of pain assessed during day and night multiplied by the duration (in hours) of sufferance from this amount of pain. The AUC during an interval is proportional to the mean intensity of pain suffered during the same interval. It is expressed in pain unit multiplied by hour

  2. Daily rescue opiates consumption

    Time frame: From the day of surgery till the 3rd postoperative day

    The unit of rescue opiates consumption equals the administration of 5mg of morphine subcutaneously. The minimum interval between 2 rescue opiates consumption is 6 hours. Thus, the rescue opiates consumption may vary from 0 to 4/day.

  3. Global subjective patient satisfaction of post-operative wound pain control

    Time frame: Assessed at the end of follow-up on Day 8

    It may vary from 0 that means a total dissatisfaction to 100% that means a complete satisfaction

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

Randomized Double-blind Trial Comparing the Post-operative Analgesic Efficacy of Local Wound Infiltration With Bupivacaine Alone to Bupivacaine With Clonidine in Posterior Spine Surgeries

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2013
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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