Conclusions

The PolyAnalgesic Consensus Committee (PACC) which was first convened over 20 years ago has been pivotal in shaping best practices for the use of Intrathecal Drug Delivery (IDD) systems over the past two decades. This update reaffirms its commitment to providing evidence- and consensus-based recommendations to enhance the safety and efficacy of IDD therapy.

Consensus Points

Consensus Point 1: Psychologic evaluation, preferably by a trained and experienced psychologist, is indicated when considering intrathecal drug delivery for nonterminal/non–cancer-related chronic pain. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 2: When considering IDD for nonterminal/non-cancer chronic pain, opioid reduction should be attempted by clinicians. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 3: When considering IDD, the discontinuation of antidepressant or anticonvulsant medications should be balanced against the risk of exacerbating preexisting psychiatric or neurologic illness. USPSTF grade B; level of certainty low; evidence level II

Consensus Point 4: When considering IDD, clinicians should attempt to optimize patient health and functional status. USPSTF grade B; level of certainty low; evidence level II

Consensus Point 5: Decision-making on intrathecal drug use should be guided by both labeling in the jurisdiction of practice and by evidence and consensus guidance in the PACC documents.

Consensus Point 6: If off-label medications are used, strict adherence to sterile compounding procedures should be followed. USPSTF grade A; level of certainty high; evidence level II

Consensus Point 7: When performing an IDD trial, physicians should consider the medication(s) used and patient factors in deciding the setting: inpatient vs outpatient. For catheter trials, an inpatient setting is recommended. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 8: Physicians should consider pharmacokinetic parameters affecting drug distribution in IDD, especially lipid solubility and systemic effects of drugs cleared from the intrathecal space, particularly for those which are highly lipophilic. USPSTF grade A; level of certainty moderate; evidence level IC

Consensus Point 9: Intrathecal trialing of ziconotide may be best performed using injections of small boluses as opposed to continuous infusion. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 10: Intrathecal catheter placement should be targeted to the optimal vertebral level to cover putative fibers involved in the neuronal transmission of pain. USPSTF grade A; level of certainty moderate; evidence level IB

Consensus Point 11: Switching modes of intrathecal catheter delivery from continuous to intermittent bolus may not produce improved outcomes. Impact on safety and efficacy both remain undetermined. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 12: The traditional implantation site for intrathecal pump placement remains in the abdominal wall. The PACC consensus committee recognizes that the practice pattern is evolving and that for many practitioners, the buttock/posterior sites and other sites may be applicable and should be considered on a case-by-case basis. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 13: IDDS implanters should follow published guidelines on perioperative management of implanted devices and time medication administration optimally to prevent infection. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 14: Clinicians should educate patients and their caregivers perioperatively about IDDS, the medications being administered, and potential adverse events. Clinicians also should be aware that the initial postimplant phase can be complicated by concomitant administration of systemic opioids. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 15: Patients with chronic noncancer pain being considered for IDD with opioids should be weaned off other systemic opioids (or to the lowest possible dose) in consultation with their physicians, and preferably weaned off benzodiazepines if medically safe to do so. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 16: Careful attention should be paid to postoperative wound healing and wound care. In the event of a complication, the intervention required depends on the cause and severity of the complication. USPSTF grade A; level of certainty high; level of evidence II

Consensus Point 17: Clinicians considering IDD should comprehend patient factors favoring a good analgesic response, including older age and low opioid dosing at baseline. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 18: A combination of opioid with bupivacaine, regardless of when the local anesthetic is added, appears to blunt opioid dose escalation, and might be beneficial from the outset of IDD. In case of low opioid dosing and localized pain in patients with chronic noncancer pain, fentanyl may be a good option in combination with bupivacaine. USPSTF grade B; level of certainty moderate; evidence level IB

Consensus Point 19: When performing an opioid rotation with IDDS, the equianalgesic dosage should be investigated and the starting dosage of the new opioid should be decreased considerably, to consider the potential difference in receptor response, and then titrated to achieve appropriate analgesia. It should be noted that in many countries, morphine is the only opioid labeled for use, and this rotation may require off-label decision-making. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 20: In combination with systemic opioid reduction or elimination, low-dose mono-opioid therapy may be useful in treating mechanical axial back pain. USPSTF grade B; level of certainty moderate; level of evidence IB

Consensus Point 21: Addition of bupivacaine at the outset of therapy may be beneficial in blunting opioid dose escalation or in treating those patients with mixed neuropathic and mechanical pain. USPSTF grade C, level of certainty moderate, level of evidence IB

Consensus Point 22: The starting dose for intrathecal ziconotide infusion should be 0.5 to 1.0 μg/d (0.02–0.04 μg/h). USPSTF grade A; level of certainty high; evidence level I

Consensus Point 23: When titrating intrathecal ziconotide dosing, an increase of no more than 0.5 μg/d with weekly reassessment is warranted. USPSTF grade B; level of certainty moderate; evidence level I

Consensus Point 24: When side effects occur, it is recommended to reduce the intrathecal infusion dose of ziconotide to the last tolerated level that relieved pain without side effects. In the setting of severe side effects, it also is recommended that ziconotide can be discontinued without the risk of withdrawal. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 25: A baseline CK level should be obtained before intrathecal ziconotide infusion is initiated and whenever symptoms of muscle weakness or pain manifest with long-term infusion. The presence of new muscle pain and/or weakness should be considered an indication to obtain this laboratory study. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 26: In troubleshooting for decreased efficacy of IDD, a stepwise approach should be used while recognizing the need for urgent interventions in appropriate situations. USPSTF grade B; level of certainty moderate; evidence level II

Consensus Point 27: Catheter malfunction and malposition represent many of the issues related to IDD, and an algorithmic approach to evaluation is suggested as outlined in this section. USPSTF grade A; level of certainty high; level of evidence II

Consensus Point 28: Ultrasound or fluoroscopic-guided access to the central fill port should be considered if there are concerns about body habitus or device positioning that make template-guided approaches less certain. USPSTF grade B; level of certainty low; level of evidence II

Consensus Point 29: Careful preoperative assessment of existing comorbidities, candidacy for anesthesia, medical optimization, preoperative imaging review, and surgical planning are crucial. USPSTF grade A; level of certainty high; level of evidence IA

Consensus Point 30: PACC recommends dorsal catheter location with catheter tip at the dermatomal level concurrent with pain if anatomically indicated. USPSTF grade B; level of certainty moderate: level of evidence II

Consensus Point 31: Recent publications classify anticoagulation risk on the basis of invasiveness. Intrathecal catheter placement is considered high risk on anticoagulation and reference to society guidelines for catheter high-risk procedures should be followed. USPSTF grade A; level of certainty high; level of evidence II

Consensus Point 32: When an intrathecal catheter becomes obsolete, various management techniques have been used and include 1) removing the old catheter with careful attention to CSF leak and 2) leaving the current catheter in situ and ensuring the complete obstruction of the lumen preventing CSF leak. At present, there is no evidence to favor one approach over the other. USPSTF grade A; level of certainty moderate; level of evidence II