Clinical trial · Interventional
Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.
Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols. Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response. We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery. We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 25G Whitacre needle | Device | — | UNRESOLVED |
| A Painbuster® catheter | Device | — | UNRESOLVED |
| Bupivacaine | Drug | — | UNRESOLVED |
| Continuous infusion of local anaesthetic | Procedure | — | UNRESOLVED |
| Diamorphine | Drug | — | UNRESOLVED |
| Spinal and infusion of local anaesthetic | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Continuous infusion of local anaesthetic
- description
- Continuous infusion of local anaesthetic into the surgical wound
- interventionNames
- Procedure: Continuous infusion of local anaesthetic
- Drug: Bupivacaine
- Device: A Painbuster® catheter
- type
- EXPERIMENTAL
- label
- Spinal and infusion of local anaesthetic
- description
- A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound
- interventionNames
- Procedure: Spinal and infusion of local anaesthetic
- Drug: Bupivacaine
- Drug: Diamorphine
- Device: A Painbuster® catheter
- Device: 25G Whitacre needle
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who are undergoing either laparoscopic or open colorectal resections will be considered eligible for the study. Exclusion Criteria: * Patients under 18 years of age. * Pregnant females. * Patients undergoing an abdominoperineal resection. * Patients who will not contemplate being randomized to receive a spinal anaesthetic. * Patients with a history of failure to place an epidural / spinal anaesthetic. * Hypersensitivity to local anaesthetics. * Lack of capacity to give consent.
References
Publications (0)
Data not yet available