Rectus sheath pain control after major abdomino-pelvic surgery

Rectus Sheath Catheters in Major Abdomino-Pelvic Surgery: a pilot randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77620476

Enrollment

Registered

2012-03-26

Start date

2012-02-15

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic cancer Cancer Malignant neoplasm of pelvis

Interventions

Epidural catheter versus rectus sheath catheter-based analgesia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with a surgical/medical condition requiring a midline laparotomy and exenterative procedure 2. Willing and able to provide informed consent for participation in the study 3. Male or female aged 18 years or over

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in the trial/provide informed consent 2. Unable to provide informed consent 3. Inappropriate surgical approach, e.g. laparoscopic 4. Contra-indications to an epidural catheter or rectus sheath catheter

Design outcomes

Primary

Measure	Time frame
Is rectus sheath catheter based analgesia equivalent to epidural based analgesia in patients undergoing major abdomino-pelvic surgery in terms of safety and efficacy? Safety is assessed by recording the number of adverse events and complications associated with the trial. Efficacy is assessed by a number of means: patient pain scores, time to mobilisation, time to flatus, time to bowel opening, and readmission rate. The measurements are taken for the duration of the in-patient stay, and then up to 31 days post-operatively to record the readmission rate during this period.	—

Measure

Time frame

Is rectus sheath catheter based analgesia equivalent to epidural based analgesia in patients undergoing major abdomino-pelvic surgery in terms of safety and efficacy? Safety is assessed by recording the number of adverse events and complications associated with the trial. Efficacy is assessed by a number of means: patient pain scores, time to mobilisation, time to flatus, time to bowel opening, and readmission rate. The measurements are taken for the duration of the in-patient stay, and then up to 31 days post-operatively to record the readmission rate during this period.

—

Secondary

Measure	Time frame
1. Procedural time 2. Total blood loss/transfusion 3. Hypotensive episodes 4. Urine output 5. Total intravenous fluids administered 6. Patient mobilisation 7. Opiate avoidane 8. Gastro-intestinal morbidity 9. Respiratory morbidity 10. Demands on nursing/medical care 11. Cost-effectiveness 12. Patient length of stay 13. Patient acceptability The measurements are taken for the duration of the in-patient stay, and then up to 31 days post-operatively to record the readmission rate during this period	—

Measure

Time frame

1. Procedural time 2. Total blood loss/transfusion 3. Hypotensive episodes 4. Urine output 5. Total intravenous fluids administered 6. Patient mobilisation 7. Opiate avoidane 8. Gastro-intestinal morbidity 9. Respiratory morbidity 10. Demands on nursing/medical care 11. Cost-effectiveness 12. Patient length of stay 13. Patient acceptability The measurements are taken for the duration of the in-patient stay, and then up to 31 days post-operatively to record the readmission rate during this period

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026