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Analgesia for Mid-line Laparotomies: Thoracic Epidural vs Restus Sheath Analgesia

NCT04262622 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-12

No results posted yet for this study

Summary

Midline laparotomies are accompanied by severe postoperative pain. Adequate post-operative pain relief after major abdominal surgery reduces complications (e.g. chest infection or deep venous thrombosis) and enhances recovery and early mobilization, with better patients' satisfaction, and less hospital stay.

The standard technique for post-operative analgesia after major abdominal surgery is thoracic epidural analgesia (TEA). On the other hand, the complications encountered with TEA motivates the search for another technique, besides that in some situations, midline incision is needed while TEA is contraindicated e.g. emergency laparotomy.

Rectus sheath nerve block (RSB) is a regional anesthetic technique that provides midline somatic analgesia and might be an alternative to TEA. It is an old technique that has been revisited because of the availability of new local anesthetic agents, and the availability of small-caliber catheters.

It was hypothesized that rectus sheath analgesia (RSA) might be an alternative to thoracic epidural analgesia. Thereby, the aim of the current study is to find whether analgesia provided through surgically placed rectus sheath catheters can be a safe and effective alternative to thoracic epidural analgesia for postoperative pain relief in patients undergoing elective midline laparotomies.

Conditions

  • Mid-line Laparotomies

Interventions

DEVICE

Group TEA: thoracic epidural analgesia group

in this group TEA will be performed by the insertion of transthoracic epidural catheter before induction of general anesthesia. Analgesia will be started on wound closure by injecting local anesthetic mixture into the epidural catheter

DEVICE

Group RSB: rectus sheath block group

Two sets of epidural catheters which have multiple perforations at the end of the tubing will be surgically applied bilaterally into the rectus sheaths for each patient in this group on wound closure. By the end of surgery,injection of local anesthetic mixture will be started.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Salwa H Waly · Faculty of medicine. Zagazig University. Egypt

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262622 on ClinicalTrials.gov