Postoperative Analgesia for Elective Mid-line Laparotomies: Thoracic Epidural Versus Surgically-placed Rectus Sheath Catheters
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Zagazig University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The change in the degree of postoperative pain
Study Overview
Brief 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.
Detailed Description
Administrative design:
- Approval is obtained from the ethics committee of faculty of medicine, IRB approval and the Department of Anesthesia and Surgical Intensive Care, Zagazig University.
- Informed written consent will be obtained from all patients in the study.
- The patient has the right to withdraw from the study at any time without negative sequences on their medical or surgical treatment plan.
Sample size:
The power of this study is calculated prospectively using G*POWER program version 3.1.9.2. (Heinrich Heine; Universitat Dusseldorf; Germany). To calculate sample size, degree of postoperative analgesia is used as the primary outcome. A pilot study (10 patients in each group) was performed to detect significant difference in the degree of postoperative analgesia (following VAS). It is found that 24 patients are needed in each group to achieve an alpha error level of 0.05, with 80% power and 95% confidence interval. Allowing a 5% drop out rate, the final sample size needed is 25 patients in each group to detect clinically significant difference of >20%.
Statistical analysis plan Categorical data will be presented as frequencies and/or percentages and analyzed with a chi-square or Fisher's exact test. Quantitative variables will be analyzed with unpaired t test. Statistical analysis will be performed using IBM SPSS Statistics (version 21). A p value equal to or less than 0.05 was considered statistically significant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient acceptance.
- •American Society of Anesthesiology (ASA) physical status classification of I - III
- •Body mass index (BMI) of 18.5-29.9 kg/m2
- •Patients who are posted for elective abdominal operations with midline incision under general anesthesia (e.g. colorectal resections including right or left hemicolectomy or segmental colonic resection).
Exclusion Criteria
- •Extensive surgery beyond midline incision (e.g. abdomino-perineal resection)
- •Coagulopathies.
- •Local infection at sites of catheters insertion.
- •Systemic sepsis.
- •Severe cardiac or respiratory disease.
- •Severe renal or hepatic impairment.
- •Allergy to drugs used in the study.
- •Known substance abuse.
Arms & Interventions
Group TEA
Intervention: Group RSB: rectus sheath block group (Device)
Group RSB
Intervention: Group TEA: thoracic epidural analgesia group (Device)
Outcomes
Primary Outcomes
The change in the degree of postoperative pain
Time Frame: 0, 3, 6, 12, 24, 36 and 48 hours; where T0= time of arrival of the patient to PACU.
The change in the degree of pain will be evaluated using according to visual analogue scale (VAS) where 0= no pain, and 10= worst pain possible. If VAS is ≥4= inadequate pain relief,
Secondary Outcomes
No secondary outcomes reported
Investigators
Salwa Hassan Waly
Associate Professor of Anesthesia and Surgical Intensive Care
Zagazig University