Postoperative PainPhase 4NCT06997016
Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
A Phase 4 study testing pre-operative carbohydrate drink, Acetaminophen and Gabapentin in people with Postoperative Pain, run by Baylor Research Institute at 1 site in United States.
Trial summary
The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- pre-operative carbohydrate drink, Acetaminophen and Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- over 18 years of age
- receiving a kidney transplant from a living donor.
Who cannot join
- delayed gastric emptying
- severe type I diabetes
- allergy to interventional medications
- pregnancy (this is a normal exclusion for kidney recipients)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 76104
About this study
The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are:
Does the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain.
Read more
Participants will be asked to:
- Drink a pre-surgery carbohydrate drink two hours before your surgery.
- Take a pre-surgery dose of Tylenol by mouth.
- Take a pre-surgery dose of Gabapentin by mouth.
- The surgeon will administer a local numbing medication at the surgery site by injection during the surgery.
- Begin walking with assistance about 12 hours after your surgery.
- Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.
- Conditions
- Postoperative Pain
- Being tested
- pre-operative carbohydrate drink, Acetaminophen, Gabapentin, Bupivacaine, Ambulation
- Keywords
- transplantation, kidney, renal transplantation, Enhanced Postsurgical Recovery, Recovery, Enhanced Postsurgical, pain, postoperative, postsurgical pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative carbohydrate drinkDietary supplement
50 g of carbohydrate drink 2 hours before surgery
AcetaminophenDrug
Also called tylenol
650mg acetaminophen 30 minutes prior to surgery
GabapentinDrug
Also called Neurontin, Gralise
300 mg gabapentin 30 minutes prior to surgery
BupivacaineDrug
Also called Marcaine, Sensorcaine
intraoperative local anesthetic
AmbulationOther
Assisted ambulation 12 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery Protocol | Experimental | This group will receive the following:
50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery Receives: Dietary Supplement: pre-operative carbohydrate drink; Drug: Acetaminophen; Drug: Gabapentin; Drug: Bupivacaine; Other: Ambulation |
| Control group | No intervention | This group is a retrospective review of 30 patients who have undergone a live donor kidney transplant during 1/1/2022-12/31/2024 will be selected and undergo a retrospective chart review for the same data collection points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) (0-10)
Patient reported pain on a scale from 0 (no pain) to 10 (the worst possible pain)
Measured: From enrollment to the end of treatment at 30 days
Narcotic Use
milligram morphine equivalents (MME)
Measured: From enrollment to the end of treatment at 30 days
Secondary outcomes (3)
Adverse Events
unfavorable medical occurence
Measured: From enrollment to the end of treatment at 30 days
Hospital readmission
readmission to any hospital within 30 days
Measured: From enrollment to the end of treatment at 30 days
Length of Stay
total hospital length of stay
Measured: From enrollment to the end of treatment at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start5 May 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Ruiz, MD, Principal investigator, Baylor Scott & White All Saints Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997016
- Sponsor's protocol ID
- Baylor IRB #025-220
- Status last verified
- Oct 2026
- First submitted
- 21 May 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06997016
- Acronym / sponsor ID
- Baylor IRB #025-220
- Conditions
- Postoperative Pain
- Keywords
- transplantation, kidney, renal transplantation, Enhanced Postsurgical Recovery, Recovery, Enhanced Postsurgical, pain, postoperative, postsurgical pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are:
Does the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain.
Participants will be asked to:
- Drink a pre-surgery carbohydrate drink two hours before your surgery.
- Take a pre-surgery dose of Tylenol by mouth.
- Take a pre-surgery dose of Gabapentin by mouth.
- The surgeon will administer a local numbing medication at the surgery site by injection during the surgery.
- Begin walking with assistance about 12 hours after your surgery.
- Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery Protocol | Experimental | Dietary Supplement: pre-operative carbohydrate drink, Drug: Acetaminophen, Drug: Gabapentin, Drug: Bupivacaine, Other: AmbulationThis group will receive the following: 50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery |
| Control group | No intervention | –This group is a retrospective review of 30 patients who have undergone a live donor kidney transplant during 1/1/2022-12/31/2024 will be selected and undergo a retrospective chart review for the same data collection points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- over 18 years of age
- receiving a kidney transplant from a living donor.
Key exclusion criteria (4 listed)
- delayed gastric emptying
- severe type I diabetes
- allergy to interventional medications
- pregnancy (this is a normal exclusion for kidney recipients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-operative carbohydrate drink50 g of carbohydrate drink 2 hours before surgery | Dietary supplement | Enhanced Recovery Protocol |
| AcetaminophenAlso: tylenol650mg acetaminophen 30 minutes prior to surgery | Drug | Enhanced Recovery Protocol |
| GabapentinAlso: Neurontin, Gralise300 mg gabapentin 30 minutes prior to surgery | Drug | Enhanced Recovery Protocol |
| BupivacaineAlso: Marcaine, Sensorcaineintraoperative local anesthetic | Drug | Enhanced Recovery Protocol |
| AmbulationAssisted ambulation 12 hours after surgery | Other | Enhanced Recovery Protocol |
Primary outcome
Numerical Rating Scale (NRS) (0-10)
Time frame: From enrollment to the end of treatment at 30 days
Patient reported pain on a scale from 0 (no pain) to 10 (the worst possible pain)
Narcotic Use
Time frame: From enrollment to the end of treatment at 30 days
milligram morphine equivalents (MME)
3 secondary outcomes
Adverse Events
Time frame: From enrollment to the end of treatment at 30 days
Hospital readmission
Time frame: From enrollment to the end of treatment at 30 days
Length of Stay
Time frame: From enrollment to the end of treatment at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Ruiz, MD principal investigator
Baylor Scott & White All Saints Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pre-operative carbohydrate drink, Acetaminophen and Gabapentin in people with Postoperative Pain, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (0-10) (time frame: From enrollment to the end of treatment at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.