Comparison of two local anaesthetic techniques for the post-operative management of acute pain following major abdominal surgery.

Comparison of Ultrasound - Guided Continuous Rectus Sheath Blockade and Continuous Preperitoneal Wound Catheter Infiltration of Local Anaesthetic for Postoperative Analgesia following Laparotomy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004702-17-IE

Enrollment

120

Registered

2011-11-04

Start date

2012-01-09

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

This study will involve the continuous infusion of local anaesthetic, into either the rectus sheath space, or the preperitoneal space, in order to achieve optimal analgesia for patients who have undergone a laparotomy. We will compare analgesic efficacy of these techniques over the first 72 hours in the postoperative period. MedDRA version: 14.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Chirocaine Product Name: Levobupivacaine Product Code: N01B B10 Pharmaceutical Form: Concentrate for solution for injection/infusion CAS Number: 27262-48-2 Current Sponsor code: 1804 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult general surgical patients presenting for laparotomy ASA 1 to 4 Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Patient refusal. Local infection at site of insertion. Allergy to amide local anaesthetics, opioids, paracetamol, NSAIDs, ketamine, NMBs, volatile anaesthetics. Concurrent use of antiarrhythmics with local anaesthetic activity. Concurrent use of MAOIs or within 2 weeks of MAOI use. Severe liver or cardiac dysfunction. Inability to comprehend pain scoring system. Elderly or debilitated patients that require a reduction in levobupivacaine dose commensurate with their physical status, resulting in the protocol not being followed. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the analgesic efficacy of continuous preperitoneal wound catheter infiltration of local anaesthetic, and continuous rectus sheath blockade, for the management of postoperative pain in the first 72 hours following laparotomy. The primary outcome is total morphine consumption in the first 72 hours.;Secondary Objective: Continuous infusion of local anaesthetic via a continuous thoracic epidural is the gold standard for the management of post-laparotomy pain. This is often combined with the use of opiates e.g. morphine. However, in many cases, due to both intrinsic patient factors, and external influences, an epidural may not be feasible. Morphine, and other opiates, have many unwanted side-effects that can result in morbidity e.g. itch, nausea+vomiting, sedation, constipation, urinary retention, respiratory depression etc. Two techniques that have been used, when central neuraxial analgesia is not possible, are the continuous bilateral rectus sheath blockade and the continuous bilateral preperitoneal wound catheter infiltration device. We plan, not only to show evidence of a reduction in total opiate consumption, but also evidence of lower complication rates, shorter high-dependency unit and inpatient stays, and reduced anaesthetic and recovery time, and high patient satisfaction. ;Primary end point(s): Total postoperative opioid consumption in the first 72 hours. All data will be collected by an investigator blinded to group allocation. ;Timepoint(s) of evaluation of this end point: Assessments will be made intraoperatively and 1, 2, 4, 6, 12, 24, 48, and 72 hours post operatively.	—

Measure

Time frame

Main Objective: To compare the analgesic efficacy of continuous preperitoneal wound catheter infiltration of local anaesthetic, and continuous rectus sheath blockade, for the management of postoperative pain in the first 72 hours following laparotomy. The primary outcome is total morphine consumption in the first 72 hours.;Secondary Objective: Continuous infusion of local anaesthetic via a continuous thoracic epidural is the gold standard for the management of post-laparotomy pain. This is often combined with the use of opiates e.g. morphine. However, in many cases, due to both intrinsic patient factors, and external influences, an epidural may not be feasible. Morphine, and other opiates, have many unwanted side-effects that can result in morbidity e.g. itch, nausea+vomiting, sedation, constipation, urinary retention, respiratory depression etc. Two techniques that have been used, when central neuraxial analgesia is not possible, are the continuous bilateral rectus sheath blockade and the continuous bilateral preperitoneal wound catheter infiltration device. We plan, not only to show evidence of a reduction in total opiate consumption, but also evidence of lower complication rates, shorter high-dependency unit and inpatient stays, and reduced anaesthetic and recovery time, and high patient satisfaction. ;Primary end point(s): Total postoperative opioid consumption in the first 72 hours. All data will be collected by an investigator blinded to group allocation. ;Timepoint(s) of evaluation of this end point: Assessments will be made intraoperatively and 1, 2, 4, 6, 12, 24, 48, and 72 hours post operatively.

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Secondary

Measure	Time frame
Secondary end point(s): Postoperative pain scores, at rest and on movement as defined by the study authors, recorded at 6 – hourly intervals in the first 72 hours after surgery. (VAS and Categorical pain Scales) •Sleep quality o 10 – point visual analogue scale; 0 = very poor, 10 = excellent •Cardiovascular haemodynamics o 6 – hourly MAP, estimated blood loss (EBL), transfusion requirements •Respiratory function •Opioid side – effects: o Sedation, Postoperative nausea, vomiting, itch. •Time to return of bowel function as defined by: o Duration of postoperative ileus or number of participants with “ileus”. o Aspirate measurement from NG. o Time to first flatus, or number of participants with delay to first flatus. o Time to first bowel motion. o Time to first oral intake, or number of participants with delay to oral intake. •Duration of hospital stay (synthetic index of recovery). •Participant acceptability of analgesic method. •Participant satisfaction with analgesia. •Resource use i.e. cost/benefit analysis. ;Timepoint(s) of evaluation of this end point: Assessments will be made intraoperatively and 1, 2, 4, 6, 12, 24, 48, and 72 hours post operatively.	—

Measure

Time frame

Secondary end point(s): Postoperative pain scores, at rest and on movement as defined by the study authors, recorded at 6 – hourly intervals in the first 72 hours after surgery. (VAS and Categorical pain Scales) •Sleep quality o 10 – point visual analogue scale; 0 = very poor, 10 = excellent •Cardiovascular haemodynamics o 6 – hourly MAP, estimated blood loss (EBL), transfusion requirements •Respiratory function •Opioid side – effects: o Sedation, Postoperative nausea, vomiting, itch. •Time to return of bowel function as defined by: o Duration of postoperative ileus or number of participants with “ileus”. o Aspirate measurement from NG. o Time to first flatus, or number of participants with delay to first flatus. o Time to first bowel motion. o Time to first oral intake, or number of participants with delay to oral intake. •Duration of hospital stay (synthetic index of recovery). •Participant acceptability of analgesic method. •Participant satisfaction with analgesia. •Resource use i.e. cost/benefit analysis. ;Timepoint(s) of evaluation of this end point: Assessments will be made intraoperatively and 1, 2, 4, 6, 12, 24, 48, and 72 hours post operatively.

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Countries

Ireland

Contacts

Public ContactKevin Clarkson

Department of Anaesthesia

kevinclarkson@yahoo.com35391544074

Outcome results

None listed

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