Postoperative AnalgesiaNCT07489872
Comparison of Intrathecal Morphine and Rectus Sheath Block for Postoperative Pain Management After Lower Abdominal Surgery With Midline Incision
A study testing Intrathecal Morphine and Rectus Sheath Block in people with Postoperative Analgesia and Pain Management, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Analgesia, Pain Management
- What is being tested?
- Intrathecal Morphine and Rectus Sheath Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Feb 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- Patients undergoing lower abdominal surgery via midline incision.
Who cannot join
- Patients with solid organ dysfunction
- Patients who receive opioid or corticosteroid medication prior to surgery
- Patients with bleeding diathesis
- Patients with psychiatric disorders
- Patients who can not be contacted after surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University School of Medicine, Istanbul
Istanbul
Marmara University School of Medicine
Istanbul
About this study
Official title: Efficacy of Analgesic Methods for Pain Control After Lower Abdominal Surgery With Midline Incision
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort.
In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements.
The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.
Read the detailed description
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort.
In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements.
The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.
- Conditions
- Postoperative Analgesia, Pain Management
- Being tested
- Intrathecal Morphine, Rectus Sheath Block
- Keywords
- intrathecal morphine, rectus sheath block, lower abdominal surgery, postoperative analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineProcedure or surgery
Patients in this group will receive 200 mcg of intrathecal morphine administered at the L3-L4 interspace prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. As part of standard perioperative care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher.
Rectus Sheath BlockProcedure or surgery
Patients in this group will receive a bilateral rectus sheath block after induction of general anesthesia but prior to surgical incision, with 20 ml solution (10 ml of 0.25% bupivacaine and 10 ml of normal saline) administered to each side, in addition to standard perioperative analgesia. As part of standard care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Active comparator | Patients in this group will receive intrathecal morphine administered prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. Standard postoperative care will also be provided. Receives: Procedure: Intrathecal Morphine |
| Bilateral Rectus Sheath Block | Active comparator | Patients in this group will receive a bilateral rectus sheath block administered after general anesthesia but prior to surgical incision, in addition to standard postoperative analgesia for pain management following lower abdominal surgery via midline incision. Receives: Procedure: Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
The total amount of intravenous tramadol administered during the first 24 hours after surgery will be recorded to evaluate postoperative analgesic requirements.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Change in QoR-15 score
Quality of recovery (QoR) will be assessed using the validated QoR-15 questionnaire both preoperatively and at 24 hours after surgery. The primary analysis will evaluate the change in score from baseline to 24 hours. The total score ranges from 0 (very poor recovery) to 150 (excellent recovery).
Measured: preoperative baseline and 24 hours postoperatively
NRS Score
Postoperative pain will be assessed using the Numeric Rating Scale (NRS: 0= no pain to 10= worst pain) at 24 hours after surgery.
Measured: 24 hours postoperatively
Functional recovery
Functional recovery will be assessed by recording the time to first mobilization, time to first oral intake, and time to return of bowel function within the first 24 hours after surgery.
Measured: 24 hours postoperatively
Rescue Analgesic Consumption
Total amount of rescue analgesics (intravenous morphine) administered within the first 24 hours postoperatively will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start24 Feb 2025
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489872
- Sponsor's protocol ID
- 09.2025.174
- Status last verified
- Nov 2026
- First submitted
- 18 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Analgesic Methods for Pain Control After Lower Abdominal Surgery With Midline Incision
- ClinicalTrials.gov ID
- NCT07489872
- Acronym / sponsor ID
- 09.2025.174
- Conditions
- Postoperative Analgesia, Pain Management
- Keywords
- intrathecal morphine, rectus sheath block, lower abdominal surgery, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort.
In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements.
The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.
Detailed description
This study aims to evaluate the efficacy of intrathecal morphine and rectus sheath block compared with standard postoperative analgesia for pain management in patients undergoing lower abdominal surgery with a midline incision. Effective postoperative analgesia is essential to enhance recovery, reduce opioid consumption, and improve overall patient comfort.
In this prospective randomized controlled trial, eligible patients scheduled for lower abdominal surgery through a midline incision will be randomly assigned to one of three groups: intrathecal morphine, rectus sheath block, or control (standard postoperative analgesia without regional intervention). Postoperative outcomes will include pain scores, quality of recovery (QoR) scores, functional recovery parameters, patient satisfaction, incidence of postoperative nausea and vomiting, and rescue analgesic requirements.
The findings of this study may provide evidence on the comparative effectiveness of these analgesic strategies and contribute to the development of optimized multimodal pain management protocols in lower abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Active comparator | Procedure: Intrathecal MorphinePatients in this group will receive intrathecal morphine administered prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. Standard postoperative care will also be provided. |
| Bilateral Rectus Sheath Block | Active comparator | Procedure: Rectus Sheath BlockPatients in this group will receive a bilateral rectus sheath block administered after general anesthesia but prior to surgical incision, in addition to standard postoperative analgesia for pain management following lower abdominal surgery via midline incision. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Patients undergoing lower abdominal surgery via midline incision.
Key exclusion criteria (5 listed)
- Patients with solid organ dysfunction
- Patients who receive opioid or corticosteroid medication prior to surgery
- Patients with bleeding diathesis
- Patients with psychiatric disorders
- Patients who can not be contacted after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal MorphinePatients in this group will receive 200 mcg of intrathecal morphine administered at the L3-L4 interspace prior to general anesthesia as part of their perioperative analgesic regimen for postoperative pain control following lower abdominal surgery with a midline incision. As part of standard perioperative care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher. | Procedure or surgery | Intrathecal Morphine |
| Rectus Sheath BlockPatients in this group will receive a bilateral rectus sheath block after induction of general anesthesia but prior to surgical incision, with 20 ml solution (10 ml of 0.25% bupivacaine and 10 ml of normal saline) administered to each side, in addition to standard perioperative analgesia. As part of standard care, all patients will receive 8 mg dexamethasone and 1.5 mg/kg intravenous tramadol. Postoperatively, all patients will have intravenous tramadol PCA (10 mg/kg). Rescue analgesia with 3 mg intravenous morphine will be administered if the numeric rating scale (NRS) pain score is 4 or higher. | Procedure or surgery | Bilateral Rectus Sheath Block |
Primary outcome
Opioid Consumption
Time frame: 24 hours postoperatively
The total amount of intravenous tramadol administered during the first 24 hours after surgery will be recorded to evaluate postoperative analgesic requirements.
4 secondary outcomes
Change in QoR-15 score
Time frame: preoperative baseline and 24 hours postoperatively
NRS Score
Time frame: 24 hours postoperatively
Functional recovery
Time frame: 24 hours postoperatively
Rescue Analgesic Consumption
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine and Rectus Sheath Block in people with Postoperative Analgesia and Pain Management, run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.