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

St Joseph University, Beirut, Lebanon

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain

Treatments: Drug: Bupivacaine; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01902108

CLON-POBPC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 225 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 2 patient groups

Clonidine

Experimental group

Description:

Clonidine 150μg added to bupivacaine in a local infiltration before wound incision

Treatment:

Drug: Clonidine

Bupivacaine

Active Comparator group

Description:

Bupivacaine 0.25 % alone in the wound infiltration

Treatment:

Drug: Bupivacaine