Postoperative PainNCT05656872
Transversus Abdominis Plane Block Versus Ilioinguinal-Iliohypogastric Nerve Block for Postoperative Analgesia Following Open Total Abdominal Hysterectomy
A study testing Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block in people with Postoperative Pain, run by Cairo University at 2 sites in Egypt.
Trial summary
The investigators hypothesised that ultrasound-guided transversus abdominis plane (TAP) block would prolong the time to first rescue nalbuphine within 24 hours compared with ultrasound-guided ilioinguinal-iliohypogastric (IIH) nerve block, by virtue of its broader dermatomal coverage (T10-L1 versus T12-L1) of the… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2022to 30 Apr 2023
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be adult patients (35-65 years)
- ASA I-III
- Scheduled for elective open TAH
Who cannot join
- Patient refusal
- BMI > 40 kg·m-²
- Pregnancy
- Chronic pain requiring daily analgesics
- Any known allergy to local anesthetic, nalbuphine, paracetamol, or diclofenac
- Patients with neurological, psychological disorders or those lacking cooperation
Show all 9Show fewer
- Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL)
- Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate
Mohamed Ollaek
Cairo
About this study
Official title: A Comparative Study Between Ultrasound-guided Transversus Abdominis Plane Block Versus Ultrasound-guided Ilioinguinal-Iliohypogastric Nerve Block for Postoperative Analgesia Following Open Total Abdominal Hysterectomy: A Randomised Comparative Trial
The investigators hypothesised that ultrasound-guided transversus abdominis plane (TAP) block would prolong the time to first rescue nalbuphine within 24 hours compared with ultrasound-guided ilioinguinal-iliohypogastric (IIH) nerve block, by virtue of its broader dermatomal coverage (T10-L1 versus T12-L1) of the Pfannenstiel incision. This hypothesis direction was established before unblinding and data analysis.
Read the detailed description
Aim of the work
the aim of the study is to compare between the analgesic effect of Transversus Abdominis Plane Block and Ilioinguinal-iliohypogastric block following open abdominal hysterectomy Objectives
- to compare between the analgesic effect of Transversus Abdominis Plane Block and Ilioinguinal-iliohypogastric block For Postoperative Analgesia following open abdominal hysterectomy
- to measure the incidence of complications following both blocks as hematoma, block failure, infection at injection site
Sample size:
Our primary outcome is the time to first rescue analgesia request. In a previous study, the meantime to first rescue analgesia was 10.58 ± 2.35 hours (6). The investigators calculated a sample size that could detect a mean difference of 20% between both study groups. MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium) was used to calculate the sample size.38 patients( 19 patients per group) at least were estimated to have a study power of 80% and an alpha error of 0.05. This number will be increased to 42 patients (21 patients per group) to compensate for possible dropouts.
Sample size calculation was performed guided by the power of 80%, confidence level of 95%.
Statistical analysis:
For data analysis, the Statistical Package for Social Science (SPSS) software, version 23.0 for Microsoft Windows (SPSS Inc., Chicago, IL, USA) was used (version 23.0 was used in place of the registered version 26; no impact on any statistical result). Python (SciPy 1.7) was additionally used for area-under-the-curve computation and Holm-Bonferroni multiplicity correction.
Normality of continuous data was assessed using the Shapiro-Wilk test and graphical inspection. Parametric data are reported as mean (standard deviation) and were compared between groups using the independent samples t test. Non-parametric data are reported as median (interquartile range [range]) and were compared using the Mann-Whitney U test. Categorical data are reported as number (proportion) and were compared using the chi-square test or Fisher exact test as appropriate.
The primary outcome time from end of surgery to first rescue nalbuphine within 24 hours was analysed as a time-to-event outcome using the Kaplan-Meier method with log-rank testing, and Cox proportional hazards regression was used to estimate the hazard ratio with 95% confidence interval. Participants who did not require rescue nalbuphine were censored at 24 hours. This approach replaced the t-test framework implied in the original registration, as Kaplan-Meier survival analysis is the methodologically appropriate method for a time-to-event outcome with censored observations. This change was made before unblinding and before any outcome data were examined.
To address multiple comparisons across the eight postoperative pain assessment time points, cumulative pain burden was calculated for each participant as the area under the numerical rating scale pain score-time curve from 5 minutes to 24 hours using the trapezoidal rule (NRS-AUC₅ₘᵢₙ-₂₄ₕ, in score·hours) and compared between groups using the Mann-Whitney U test. Individual time-point comparisons were considered exploratory and p values were adjusted using the Holm-Bonferroni stepwise correction in place of the Bonferroni post-hoc ANOVA approach registered originally; this substitution is more statistically appropriate as it controls the familywise error rate with greater power. Cohen's d was calculated from group means and standard deviations as a supplementary standardised effect-size measure.
All tests were two-sided with α = 0.05. Exact p values are reported throughout rather than thresholds (e.g., p < 0.05). All 42 randomised participants completed 24-hour follow-up and were included in the analysis (intention-to-treat).
- Conditions
- Postoperative Pain
- Being tested
- Transverse Abdominis Plane Block, Ilioinguinal-iliohypogastric block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Abdominis Plane BlockProcedure or surgery
Group T, will be performed in a supine position after skin sterilization, a linear high-frequency transducer GE Healthcare 12L-RS ultrasound will be placed in the transverse plane to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. The abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) will be visualized. A blunt tip,20-gauge, short bevel needle(B Braun Contiplex 22G echogenic needle, 80-100 mm) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. Separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in-between will be observed. The procedure will be repeated following the same steps on the other side.
Ilioinguinal-iliohypogastric blockProcedure or surgery
Group I, will receive an Ultrasound-guided IIIH block that will be performed in a supine position after skin sterilization, a linear high-frequency transducer GE Healthcare 12L-RS ultrasound will be placed on the line between the anterior superior iliac spine and the umbilicus, where 3 layers of muscles (extra-abdominal oblique, intra-abdominal oblique, and transverse abdominis) will be visible on the inner side of the anterior superior iliac spine.A blunt tip,20-gauge, short bevel needle( Braun Contiplex 22G echogenic needle, 80-100 mm) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle next to the iliohypogastric/ilioinguinal nerve. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. The procedure will be repeated following the same steps on the other side.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Active comparator | Transversus abdominus plane (TAP) block will be used as postoperative analgesia Receives: Procedure: Transverse Abdominis Plane Block |
| IIIH Block | Active comparator | Ilioinguinal-iliohypogastric (IIIH) block will be used as postoperative analgesia Receives: Procedure: Ilioinguinal-iliohypogastric block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue nalbuphine within 24 hours
Time from end of surgery to first administration of rescue nalbuphine (0.15 mg.kg-¹ intravenously, given when numerical rating scale pain score ≥ 4 at rest after 30 minutes).
Measured: From end of surgery to first rescue dose within 24 hours postoperatively
Secondary outcomes (4)
Total nalbuphine consumption within 24 hours
Total cumulative dose of rescue nalbuphine (mg) administered to each participant from end of surgery to 24 hours postoperatively.
Measured: Immediate 24 hours post-operative
Numerical Rating Scale (NRS)
Pain intensity at rest measured using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).
Measured: 5 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, and 24 hours after arrival in the post-anaesthesia care unit
Intraoperative and postoperative haemodynamics (heart rate and mean arterial pressure)
Heart rate (beats per minute) and mean arterial pressure (mmHg) recorded at baseline (before induction), 1 minute after intubation, every 10 minutes intraoperatively, immediately after extubation, 5 minutes after extubation, and every 10 minutes in the post-anaesthesia care unit for 30 minutes. Postoperative assessments also recorded at 2, 4, 8, 12, 18, and 24 hours.
Measured: Baseline, every 10 minutes intraoperatively, immediately after extubation, 5 minutes after extubation, every 10 minutes in PACU for 30 minutes, then at 2, 4, 8, 12, 18, and 24 hours postoperatively
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting
Measured: Immediate 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Nov 2022
- Primary completion28 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssef, Cairo University
- Investigators
- Mohamed A Ollaek, MD, Principal investigator, Department of Anesthesia, Surgical ICU and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656872
- Sponsor's protocol ID
- MS-617-2021
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2022
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound-guided Transversus Abdominis Plane Block Versus Ultrasound-guided Ilioinguinal-Iliohypogastric Nerve Block for Postoperative Analgesia Following Open Total Abdominal Hysterectomy: A Randomised Comparative Trial
- ClinicalTrials.gov ID
- NCT05656872
- Acronym / sponsor ID
- MS-617-2021
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Dec 2022 (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.
The investigators hypothesised that ultrasound-guided transversus abdominis plane (TAP) block would prolong the time to first rescue nalbuphine within 24 hours compared with ultrasound-guided ilioinguinal-iliohypogastric (IIH) nerve block, by virtue of its broader dermatomal coverage (T10-L1 versus T12-L1) of the Pfannenstiel incision. This hypothesis direction was established before unblinding and data analysis.
Detailed description
Aim of the work
the aim of the study is to compare between the analgesic effect of Transversus Abdominis Plane Block and Ilioinguinal-iliohypogastric block following open abdominal hysterectomy Objectives
- to compare between the analgesic effect of Transversus Abdominis Plane Block and Ilioinguinal-iliohypogastric block For Postoperative Analgesia following open abdominal hysterectomy
- to measure the incidence of complications following both blocks as hematoma, block failure, infection at injection site
Sample size:
Our primary outcome is the time to first rescue analgesia request. In a previous study, the meantime to first rescue analgesia was 10.58 ± 2.35 hours (6). The investigators calculated a sample size that could detect a mean difference of 20% between both study groups. MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium) was used to calculate the sample size.38 patients( 19 patients per group) at least were estimated to have a study power of 80% and an alpha error of 0.05. This number will be increased to 42 patients (21 patients per group) to compensate for possible dropouts.
Sample size calculation was performed guided by the power of 80%, confidence level of 95%.
Statistical analysis:
For data analysis, the Statistical Package for Social Science (SPSS) software, version 23.0 for Microsoft Windows (SPSS Inc., Chicago, IL, USA) was used (version 23.0 was used in place of the registered version 26; no impact on any statistical result). Python (SciPy 1.7) was additionally used for area-under-the-curve computation and Holm-Bonferroni multiplicity correction.
Normality of continuous data was assessed using the Shapiro-Wilk test and graphical inspection. Parametric data are reported as mean (standard deviation) and were compared between groups using the independent samples t test. Non-parametric data are reported as median (interquartile range [range]) and were compared using the Mann-Whitney U test. Categorical data are reported as number (proportion) and were compared using the chi-square test or Fisher exact test as appropriate.
The primary outcome time from end of surgery to first rescue nalbuphine within 24 hours was analysed as a time-to-event outcome using the Kaplan-Meier method with log-rank testing, and Cox proportional hazards regression was used to estimate the hazard ratio with 95% confidence interval. Participants who did not require rescue nalbuphine were censored at 24 hours. This approach replaced the t-test framework implied in the original registration, as Kaplan-Meier survival analysis is the methodologically appropriate method for a time-to-event outcome with censored observations. This change was made before unblinding and before any outcome data were examined.
To address multiple comparisons across the eight postoperative pain assessment time points, cumulative pain burden was calculated for each participant as the area under the numerical rating scale pain score-time curve from 5 minutes to 24 hours using the trapezoidal rule (NRS-AUC₅ₘᵢₙ-₂₄ₕ, in score·hours) and compared between groups using the Mann-Whitney U test. Individual time-point comparisons were considered exploratory and p values were adjusted using the Holm-Bonferroni stepwise correction in place of the Bonferroni post-hoc ANOVA approach registered originally; this substitution is more statistically appropriate as it controls the familywise error rate with greater power. Cohen's d was calculated from group means and standard deviations as a supplementary standardised effect-size measure.
All tests were two-sided with α = 0.05. Exact p values are reported throughout rather than thresholds (e.g., p < 0.05). All 42 randomised participants completed 24-hour follow-up and were included in the analysis (intention-to-treat).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Active comparator | Procedure: Transverse Abdominis Plane BlockTransversus abdominus plane (TAP) block will be used as postoperative analgesia |
| IIIH Block | Active comparator | Procedure: Ilioinguinal-iliohypogastric blockIlioinguinal-iliohypogastric (IIIH) block will be used as postoperative analgesia |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be adult patients (35-65 years)
- ASA I-III
- Scheduled for elective open TAH
Key exclusion criteria (9 listed)
- Patient refusal
- BMI > 40 kg·m-²
- Pregnancy
- Chronic pain requiring daily analgesics
- Any known allergy to local anesthetic, nalbuphine, paracetamol, or diclofenac
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 |
|---|---|---|
| Transverse Abdominis Plane BlockGroup T, will be performed in a supine position after skin sterilization, a linear high-frequency transducer GE Healthcare 12L-RS ultrasound will be placed in the transverse plane to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest. The abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) will be visualized. A blunt tip,20-gauge, short bevel needle(B Braun Contiplex 22G echogenic needle, 80-100 mm) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. Separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in-between will be observed. The procedure will be repeated following the same steps on the other side. | Procedure or surgery | TAP Block |
| Ilioinguinal-iliohypogastric blockGroup I, will receive an Ultrasound-guided IIIH block that will be performed in a supine position after skin sterilization, a linear high-frequency transducer GE Healthcare 12L-RS ultrasound will be placed on the line between the anterior superior iliac spine and the umbilicus, where 3 layers of muscles (extra-abdominal oblique, intra-abdominal oblique, and transverse abdominis) will be visible on the inner side of the anterior superior iliac spine.A blunt tip,20-gauge, short bevel needle( Braun Contiplex 22G echogenic needle, 80-100 mm) will be inserted in-plane and advanced anterior to posterior under continuous visualization until the tip reaches between the internal oblique and the transversus abdominis muscle next to the iliohypogastric/ilioinguinal nerve. After negative aspiration, 20 mL of bupivacaine 0.25%, lidocaine 1% will be injected. The procedure will be repeated following the same steps on the other side. | Procedure or surgery | IIIH Block |
Primary outcome
Time to first rescue nalbuphine within 24 hours
Time frame: From end of surgery to first rescue dose within 24 hours postoperatively
Time from end of surgery to first administration of rescue nalbuphine (0.15 mg.kg-¹ intravenously, given when numerical rating scale pain score ≥ 4 at rest after 30 minutes).
4 secondary outcomes
Total nalbuphine consumption within 24 hours
Time frame: Immediate 24 hours post-operative
Numerical Rating Scale (NRS)
Time frame: 5 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 18 hours, and 24 hours after arrival in the post-anaesthesia care unit
Intraoperative and postoperative haemodynamics (heart rate and mean arterial pressure)
Time frame: Baseline, every 10 minutes intraoperatively, immediately after extubation, 5 minutes after extubation, every 10 minutes in PACU for 30 minutes, then at 2, 4, 8, 12, 18, and 24 hours postoperatively
Incidence of postoperative nausea and vomiting
Time frame: Immediate 24 hours post-operative
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 28 Apr 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.
Mohamed A Ollaek, MD principal investigator
Department of Anesthesia, Surgical ICU and Pain Management
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block in people with Postoperative Pain, run by Cairo University at 2 sites in Egypt.
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 3 inclusion and 9 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 28 Apr 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 Egypt. 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?
Time to first rescue nalbuphine within 24 hours (time frame: From end of surgery to first rescue dose within 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 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.