Can optimized postoperative pain management improve outcomes after an operation for oesophageal cancer (cancer of the gullet)?
| ISRCTN | ISRCTN16853684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16853684 |
| Sponsor | Uppsala University |
| Funders | Nordic Cancer Union, Cancerfonden |
- Submission date
- 28/01/2026
- Registration date
- 29/01/2026
- Last edited
- 30/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is designed to investigate the effects, if any, of different strategies for pain management on the recovery process after an operation for oesophageal cancer (cancer of the gullet).
Who can participate?
Patients aged 18 years and over planned for a minimally invasive (keyhole surgery) operation for oesophageal cancer
What does the study involve?
Participants are randomly allocated to have paravertebral local analgesia or standard postoperative epidural analgesia.
What are the possible benefits and risks of participating?
Both methods used in this trial are approved and we want to uncover differences, if any, in the recovery process. The risks are very small.
Where is the study run from?
This study is led from Uppsala University (Sweden) and also involves academic centers from Norway, Denmark, Finland, Iceland and Italy.
When is the study starting and how long is it expected to run for?
September 2026 to July 2033
Who is funding the study?
1. Nordic Cancer Union
2. Swedish Cancer Society
Who is the main contact?
Dr Jakob Hedberg, jakob.hedberg@surgsci.uu.se
Contact information
Principal investigator, Scientific
Akademiska Sjukhuset in 70
Uppsala
75185
Sweden
 ORCID ID |
0000-0003-1308-4592 |
|---|---|
| Phone | +46 (0)186116507 |
| jakob.hedberg@me.com |
Public
Akademiska Sjukhuset in 70
Uppsala
75185
Sweden
| Phone | +46 (0)6119993 |
|---|---|
| jakob.hedberg@surgsci.uu.se |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Health services research, Treatment | |
| Scientific title | Paravertebral Block AnaLgesia vs. epidural: Assessing Novel Care in Esophagectomy (BALANCE): a multi-center randomized Phase III trial | |
| Study acronym | BALANCE | |
| Study objectives | To provide high-level evidence on the benefits/risks of epidural analgesia in minimally invasive esophagectomy. | |
| Ethics approval(s) |
Not yet submitted | |
| Health condition(s) or problem(s) studied | Oesophageal cancer | |
| Intervention | Randomisation: Participants are enrolled and randomized consecutively as they are found to be eligible for inclusion in the trial. Randomization is performed no later than 12 h before surgery. If a participant discontinues participation, the participant's trial-specific code will not be reused, and the participant will not be allowed to re-enter the trial. Randomization will be performed online from within an electronic randomization system, after a multidisciplinary tumor board meeting, once all eligibility criteria have been verified and no exclusion criteria have been fulfilled. Randomization will be stratified by country and level of anastomosis (chest/neck). The electronic randomization module is accessed from each participating site. Treatment allocation will be open-label, among the two intervention arms at a 1:1 ratio of paravertebral block and opioid PCA (intervention) or standard EDA treatment (control). Intervention: Participants who are randomized to intervention will receive a paravertebral block at the end of the thoracic phase of surgery. Local anesthetics injected under thoracoscopic vision in 1-4 sites in the intercostal space 3-8 according to local routines. As always, attention to not inject in vessels (aspiration) is crucial. Abdominal port sites are also injected according to local routines. Permitted drugs and combinations are: monotherapy, preferably bupivacaine 2.5 mg/ml (total volume 40-60 ml). Alternatively, ropivacain 3.75 mg/ml (total volume 40-60 ml) can be used. Dexamethasone or betamethasone IV 8 mg Klonidin 75-150 µg IV (optional per center but same in both arms). In addition, patient-controlled analgesia with opioids according to local protocols is used in this arm. Control: Participants who are randomized to control will receive routine EDA according to local routines at level Th6-10. After correct placement of the epidural catheter, a local anesthetic (ropivacaine, levobupivacaine, or bupivacaine) is used and according to in-house protocols, an opioid will be added to the epidural solution. Follow up: All primary and secondary outcomes will be recorded 30 days after surgery with the exception of survival which will be followed for 5 years. | |
| Intervention type | Procedure/Surgery | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 28/07/2033 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 550 |
| Key inclusion criteria | Adult (≥18 years of age) patients undergoing minimally invasive oesophagectomy with gastric conduit reconstruction due to confirmed cancer (cT1 N+ or cT2-4a any N; M0-1) |
| Key exclusion criteria | 1. Epidural analgesia contraindicated, i.e., known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens 2. Use of anticoagulants precluding EDA use 3. No postoperative nasogastric tube 4. No ability to understand the study in terms of risk and benefits (including language difficulties) 5. The participant has any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would, in the judgment of the investigator, pose excess risk associated with study participation or that, in the judgment of the investigator, would make the patient inappropriate for entry into the trial |
| Date of first enrolment | 01/09/2026 |
| Date of final enrolment | 31/07/2028 |
Locations
Countries of recruitment
- Denmark
- Finland
- Iceland
- Italy
- Norway
- Sweden
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 26/01/2027 | 30/01/2026 | No | No |
Additional files
- ISRCTN16853684_PROTOCOL_V1_26Jan2027.pdf
- Protocol file
Editorial Notes
30/01/2026: Protocol uploaded.
29/01/2026: Study's existence confirmed by Nordic Cancer Union.
