Clinical trial · Interventional
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery as Part of an Enhanced Recovery After Surgery Protocol: A Randomized Prospective Single- Center Trial.
NCT02958566CI-TRIAL-00026525unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The General Objective of this study is to investigate the cost and efficacy of treating patients undergoing colorectal surgical resections with an opioid limited pain control regimen as part of an Enhanced Recovery After Surgery (ERAS) Protocol. This group will be compared to a traditional opioid based pain control regimen.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Diverticulosis | — | UNRESOLVED | — |
| Colonic Diverticulitis | — | UNRESOLVED | — |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Constipation | — | UNRESOLVED | — |
| Constipation Drug Induced | — | UNRESOLVED | — |
| Ileus | — | UNRESOLVED | — |
| Ileus; Mechanical | — | UNRESOLVED | — |
| Ileus Paralytic | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Rectum Cancer | Rectal Carcinoma | ALIAS |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Dilaudid | Drug | — | UNRESOLVED |
| Fentanyl | Drug | — | UNRESOLVED |
| Gabapentin | Drug | — | UNRESOLVED |
| HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET | Drug | — | UNRESOLVED |
| Hydrocodone-Acetaminophen Tab 5-325 MG | Drug | — | UNRESOLVED |
| Ketamine | Drug | — | UNRESOLVED |
| Ketorolac | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Narcotic
- description
- Morphine, Dilaudid or Fentanyl patient controlled anesthesia (PCA) for the immediate postoperative period, in addition to Norco 5-325 mg 1-2 tabs Q4H PRN, or equivalent medication. Post-operative day 1: PCA will be discontinued and the patients will have IV narcotics PRN: Morphine 1-2 mg Q2H PRN, fentanyl 50-75 mcg Q2H PRN or Dilaudid 0.5 mg Q2H PRN
- interventionNames
- Drug: Morphine Sulfate
- Drug: Fentanyl
- Drug: Dilaudid
- Drug: HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET
- type
- EXPERIMENTAL
- label
- Non-Narcotic
- description
- Gabapentin 300 mg PO, orphenadrine 60 mg IV, acetaminophen 1000 mg PO or IV on Morning of surgery. Lidocaine 100 mg prior to incision, lidocaine 1mg/kg/hour during procedure, marcaine in all incisions. Ketamine and methadone per anesthesia. Acetaminophen 1000 mg PO or IV, gabapentin 300 mg PO, tramadol 50 mg PO in PACU. Acetaminophen 600 mg PO Q 6 hours, tramadol 50 mg PO Q 6 hours, gabapentin 300 mg PO Q 6 hours, orphenadrine 60 mg IV Q 12 hours, ketorolac 15 mg IV Q 6 hours for 48 hours post-operatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females above the age of 18 * Patients undergoing laparoscopic or robotic colorectal resections Exclusion Criteria: * History of constipation * Pre-existing use of narcotics or opioids * Pre-existing renal or hepatic failure * Mental illness, mental retardation, or inability to participate in informed consent due to mental status * Pre-existing dementia * Allergy to any protocol medication * Emergency operation * Subjects who are incarcerated or wards of the state * Minors * Subjects with inflammatory bowel disease, active colitis, or pre-existing intra-abdominal inflammation. Diverticulitis without active infection/inflammation will not be excluded.
References
Publications (3)
- RESULTMuller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1. PMID 19135997
- RESULTSerclova Z, Dytrych P, Marvan J, Nova K, Hankeova Z, Ryska O, Slegrova Z, Buresova L, Travnikova L, Antos F. Fast-track in open intestinal surgery: prospective randomized study (Clinical Trials Gov Identifier no. NCT00123456). Clin Nutr. 2009 Dec;28(6):618-24. doi: 10.1016/j.clnu.2009.05.009. Epub 2009 Jun 17. PMID 19535182
- RESULTLubawski J, Saclarides T. Postoperative ileus: strategies for reduction. Ther Clin Risk Manag. 2008 Oct;4(5):913-7. doi: 10.2147/tcrm.s2390. PMID 19209273