Post-operative Pain After Posterior Vaginal RepairNCT03939910
Effect of Preemptive Pudendal Nerve Block Using Bupivacaine Versus Ropivacaine on Post-operative Pain After Posterior Vaginal Repair.
A study testing Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet. in people with Post-operative Pain After Posterior Vaginal Repair, run by Munazzah Rafique.
Trial summary
To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain After Posterior Vaginal Repair
- What is being tested?
- Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 30 Jun 2021
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing posterior vaginal repair.
- Give informed written consent.
- Recruited from the urogynecology department, women specialized hospital, King Fahad Medical City, Riyadh
Who cannot join
- Posterior vaginal repair combined with Uterine suspension procedures [sacrospinous suspension or uterosacral suspension]
- Allergy to high risk to use of bupivacaine or ropivacaine
- coagulopathy
- pre-existing neurologic deficit
- Chronic pain syndromes
- BMI > 40 kg/m2
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Preemptive Pudendal Nerve Block Using Bupivacaine Versus Ropivacaine on Post-operative Pain After Posterior Vaginal Repair, Randomized Controlled Trial
To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block.
Primary outcome:
The primary outcome measures of the study visual analogue pain scores and postoperative analgesic consumption.
Read the detailed description
Preemptive analgesia is widely used during surgical procedures to reduce post-operative pain. Pudendal nerve blockade has been established and provides highly effective and safe anaesthesia to the vulva, lower vagina, and perineum. Various local anaesthetics used in gynaecological practice, including lidocaine, bupivacaine and mepivacaine. Using Bupivacaine in the Pudendal block has shown controversial results. The use of Ropivacaine as preemptive analgesia in different nerve blocks, including nerve block on the face, thorax, abdominal and perineal region, and had shown to be effective.
Bupivacaine and ropivacaine both are commonly used for peripheral nerve blocks. ropivacaine has been shown in two randomized control trials to improved postoperative analgesia and quicker recovery, compared to placebo [28,29]. Previous studies showed the promising effect on different nerve blocks including nerve block on the face, thorax, abdominal and perineal region. However, there are no studies done to investigate the effect of ropivacaine or in comparing their analgesic duration in the setting of a pudendal nerve block for gynaecological surgeries. Therefore, this study aims to conduct a comparison of the duration of postoperative analgesia achieved by two agents.
Therefore, this study aims to conduct a randomized comparison of the duration of postoperative analgesia achieved by pudendal nerve blockade using ropivacaine compared to bupivacaine, in women undergoing posterior vaginal repair. The primary outcome is pain scores and postoperative analgesic consumption, and secondary outcomes include post-operative recovery, ambulation and measure length of hospital stay.
Hypothesis:
Investigators assume that using the Preemptive pudendal nerve block will reduce the postoperative pain and decrease the postoperative analgesic demand in patients who undergo posterior vaginal repair.
The objective:
To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after the posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block.
Study Design:
Double-blind randomized controlled trial.
Sample size:
While bearing with the postoperative analgesia consumption (Morphine) over 24 hours as Primary Outcome of interest, presuming Ropivacaine is equivalent to Bupivacaine, the estimated sample size at 95% confidence interval for each arm with 80% power to detect non-inferiority using two-tailed t-test is 30 respectively. Therefore, the total patient required is 60. However, while baring with the 20% patient dropout rate, the estimated sample size for each arm is 36, a total of 72 patients.
Methodology:
Patients will be recruited randomly from urogynecology clinic after fulfilling the inclusion and exclusion criteria, who will undergo posterior vaginal wall repair. Research assistants in the pre-operative anaesthetic clinic will approach patients scheduled for surgery for participation. Patients providing informed consent (Appendix 1) will be allocated to one of two groups using a computer-generated random number table, and blinding of group allocation will be maintained with sequentially numbered, sealed, opaque envelopes. All other personnel - patients, anesthesiologists or caring for the patient in the operating theatre, surgeons, research assistants performing outcome measures, and statisticians - will remain blinded.
The patient will be explained about the risks, benefits and complications and file will be labelled as A or B for that particular patient by computer generated software. The patient can have surgery under spinal or general anaesthesia. Block will be done in the operating room, by the surgeon, just prior to starting the procedure, through the transvaginal approach. One group of patients will receive analgesia, bupivacaine 0.25% to be prepared by the pharmacologist, while the other group will receive ropivacaine 0.2 % in the syringe prepared for the pudendal block. A pharmacist will label syringe as A and B. The enrollment in the study is voluntary.
Work plan:
Pharmacologist role prepare and label two syringes: bupivacaine 0.25% syringe, and Ropivacaine 0.5% syringe. Operating Room nurse will keep two syringes labelled A and B. Before operation nurse will give the surgeon labelled syringe. Postoperatively research nurse will assess the postoperative pain intensity by visual analogue pain scale, as well as analgesic requirements, at 1, 3, 5, 7, 18, 24, and 36 hours.
Pudendal nerve block technique:
All subjects will receive prophylaxis antibiotics [Cefoxitin 2 g intravenously or similar] within one hour before surgery. All surgeries performed transvaginally under general or spinal anaesthesia. Three attending physicians will supervise all surgeries.
Patients will receive a pudendal nerve block injection on each side as previously described 5-10 minutes before the beginning of surgery. A tubular director that allows 1.0-1.5 cm of a 15-cm-long, 22-gauge needle to protrude beyond its tip will be used to guide the needle into the pudendal trunk at lesser sciatic foramen about 1 cm inferior-medial to attachment of the sacrospinous ligament to the ischial spine. The end of the director will be placed against the vaginal epithelium just beneath the tip of the ischial spine. The needle pushed beyond the tip of the director, and 5 ml of the anaesthetic solution will be injected. The needle advanced 1 cm posterior and lateral, and another 5 mL of the anaesthetic solution will be injected into this region. Aspiration will be attempted before every injection to guard against intravascular infusion.
Pain assessment protocols:
investigators will use a validated visual analogue pain scale at 1, 3, 5, 7, 18, 24 and 36 hours after surgery to assess postoperative pain intensity. This pain scale provides a validated and minimally intrusive measure of pain intensity, consisting of a 10-cm vertical line with the two endpoints labelled "no pain" and "worst possible pain." The patient is required to mark the 10-cm line at a point that corresponds to the present level of pain intensity. The distance in centimetres from the low end of the visual analogue scale and the patient's mark are used as a numerical index of pain intensity. To ensure that the questions will be asked in the same way each time, the nursing staff will be trained and instructed to phrase the questions in a standardized fashion, using the specific wording, as follows: "How bad is participant's pain? and mark participant's pain intensity on the pain scale from 0 to 10, where 0 indicates no pain and 10 indicate the worst possible pain. Analgesic requirements will consistently be recorded at 1, 3, 7, 18, and 24 hours after surgery.
Post-operative analgesia:
All patients will be given the following, unless allergic, Paracetamol 1 gm orally every 4 hours, and non-steroidal analgesia in the form of ibuprofen 400 mg orally 8 hourly, to diclofenac 50 mg rectally, 8 hourly, and Tramadol, up to 100 mg orally 8 hourly as required, and analgesia requirement will tabulate in the chart.
Statistical analysis:
Data collection Data will be collected on a customized case report form that includes all relevant demographic and intra-operative data as well as each outcome sought. Patients will be provided with a home diary to complete that will capture all outcomes sought that are not obtained in the hospital. Demographic data will be summarized and expressed using appropriate measures of central tendency and dispersion for continuous data, and frequency for categorical data. The primary outcome, time to the first sensation of pain at the surgical site, will be summarized as mean [SD] or median [IQR] after testing the data for normality with the Kolmogorov Smirnoff test. This will also determine whether groups will be compared with the t-test [for normally distributed data] or Kaplan Meier Survival Curves [for skewed data]. Secondary outcomes that are time-based will also be assessed in the above manner [time to first analgesic request, duration of motor block]. Continuous secondary outcomes [opioid consumption, VRS, room air SpO2] will be assessed with repeated measures ANOVA or the Mann Whitney U-test for non-parametric data. Categorical outcomes will be compared with the Chi-square or Fisher's exact test as necessary.
Ethics:
The approval from the King Fahad Medical City institutional review board [IRB] is taken.
Budget:
Total Budget will be based on estimation according to cost and protocol, and IRF will be obtained
- Being tested
- Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.Device
Patients will receive a pudendal nerve block injection on each side as previously described 5-10 minutes before the beginning of surgery. A tubular director that allows 1.0-1.5 cm of a 15-cm-long, 22-gauge needle to protrude beyond its tip will be used to guide the needle into the pudendal trunk at lesser sciatic foramen about 1 cm inferior-medial to attachment of the sacrospinous ligament to the ischial spine. The end of the director will be placed against the vaginal epithelium just beneath the tip of the ischial spine. The needle pushed beyond the tip of the director, and 5 ml of the anaesthetic solution will be injected. The needle advanced 1 cm posterior and lateral, and another 5 mL of the anaesthetic solution will be injected into this region.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | bupivacaine 0.25% for pudendal block Receives: Device: Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet. |
| Intervention arm | Experimental | ropivacaine 0.2 % for the pudendal block Receives: Device: Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain assessment
visual analogue scale for will be used for post operative pain assessment from scale 1 to 10. A higher score indicate worse outcome.
Measured: change in pain score from one hour up to 36 hours after surgery will be recorded.
postoperative analgesic consumption.
grams or miligrams of intravenous or oral analegesics will be recorded and minimum and maximum amount needed will be recorded. A higher amount indicate worse outcome. An average will be calculated.
Measured: from one hour up to 36 hours after surgery will be recorded.
Secondary outcomes (4)
Post-operative recovery
It will be determined by patient ambulation, return to normal diet and activity and resumption of bowl and bladder function.
Measured: up to 6 weeks follow up appointment.
Length of hospital stay.
Total number of time spent in hospital
Measured: The stay in hospital up to 36 hours to 2 days
Adverse reaction of analgesic
To observe for Potential complications that are rare and include:
- Hematoma formation from perforation of a blood vessel during needle insertion. Patients with bleeding diatheses may also be at risk.
- Infection at the site of injection. A localized infection may spread into the retro-psoas space, gluteal muscle, or hip joint
- Ischial region paresthesia or sacral neuropathy
- Systemic toxicity after intravascular administration.
Measured: from 1 hour up to 36 hours postoperatively
Patient satisfaction
Whether patient is Satisfied, Partially satisfied, Unsatisfied by direct questioning will be recorded.
Measured: up to 6 weeks postoperative followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain After Posterior Vaginal RepairStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munazzah Rafique
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Munazzah Rafique, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939910
- Sponsor's protocol ID
- MRafique
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need to discuss an ethical committee for feasibility
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preemptive Pudendal Nerve Block Using Bupivacaine Versus Ropivacaine on Post-operative Pain After Posterior Vaginal Repair, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03939910
- Acronym / sponsor ID
- MRafique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Munazzah RafiqueOther government
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 May 2019 (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.
To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block.
Primary outcome:
The primary outcome measures of the study visual analogue pain scores and postoperative analgesic consumption.
Detailed description
Preemptive analgesia is widely used during surgical procedures to reduce post-operative pain. Pudendal nerve blockade has been established and provides highly effective and safe anaesthesia to the vulva, lower vagina, and perineum. Various local anaesthetics used in gynaecological practice, including lidocaine, bupivacaine and mepivacaine. Using Bupivacaine in the Pudendal block has shown controversial results. The use of Ropivacaine as preemptive analgesia in different nerve blocks, including nerve block on the face, thorax, abdominal and perineal region, and had shown to be effective.
Bupivacaine and ropivacaine both are commonly used for peripheral nerve blocks. ropivacaine has been shown in two randomized control trials to improved postoperative analgesia and quicker recovery, compared to placebo [28,29]. Previous studies showed the promising effect on different nerve blocks including nerve block on the face, thorax, abdominal and perineal region. However, there are no studies done to investigate the effect of ropivacaine or in comparing their analgesic duration in the setting of a pudendal nerve block for gynaecological surgeries. Therefore, this study aims to conduct a comparison of the duration of postoperative analgesia achieved by two agents.
Therefore, this study aims to conduct a randomized comparison of the duration of postoperative analgesia achieved by pudendal nerve blockade using ropivacaine compared to bupivacaine, in women undergoing posterior vaginal repair. The primary outcome is pain scores and postoperative analgesic consumption, and secondary outcomes include post-operative recovery, ambulation and measure length of hospital stay.
Hypothesis:
Investigators assume that using the Preemptive pudendal nerve block will reduce the postoperative pain and decrease the postoperative analgesic demand in patients who undergo posterior vaginal repair.
The objective:
To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after the posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block.
Study Design:
Double-blind randomized controlled trial.
Sample size:
While bearing with the postoperative analgesia consumption (Morphine) over 24 hours as Primary Outcome of interest, presuming Ropivacaine is equivalent to Bupivacaine, the estimated sample size at 95% confidence interval for each arm with 80% power to detect non-inferiority using two-tailed t-test is 30 respectively. Therefore, the total patient required is 60. However, while baring with the 20% patient dropout rate, the estimated sample size for each arm is 36, a total of 72 patients.
Methodology:
Patients will be recruited randomly from urogynecology clinic after fulfilling the inclusion and exclusion criteria, who will undergo posterior vaginal wall repair. Research assistants in the pre-operative anaesthetic clinic will approach patients scheduled for surgery for participation. Patients providing informed consent (Appendix 1) will be allocated to one of two groups using a computer-generated random number table, and blinding of group allocation will be maintained with sequentially numbered, sealed, opaque envelopes. All other personnel - patients, anesthesiologists or caring for the patient in the operating theatre, surgeons, research assistants performing outcome measures, and statisticians - will remain blinded.
The patient will be explained about the risks, benefits and complications and file will be labelled as A or B for that particular patient by computer generated software. The patient can have surgery under spinal or general anaesthesia. Block will be done in the operating room, by the surgeon, just prior to starting the procedure, through the transvaginal approach. One group of patients will receive analgesia, bupivacaine 0.25% to be prepared by the pharmacologist, while the other group will receive ropivacaine 0.2 % in the syringe prepared for the pudendal block. A pharmacist will label syringe as A and B. The enrollment in the study is voluntary.
Work plan:
Pharmacologist role prepare and label two syringes: bupivacaine 0.25% syringe, and Ropivacaine 0.5% syringe. Operating Room nurse will keep two syringes labelled A and B. Before operation nurse will give the surgeon labelled syringe. Postoperatively research nurse will assess the postoperative pain intensity by visual analogue pain scale, as well as analgesic requirements, at 1, 3, 5, 7, 18, 24, and 36 hours.
Pudendal nerve block technique:
All subjects will receive prophylaxis antibiotics [Cefoxitin 2 g intravenously or similar] within one hour before surgery. All surgeries performed transvaginally under general or spinal anaesthesia. Three attending physicians will supervise all surgeries.
Patients will receive a pudendal nerve block injection on each side as previously described 5-10 minutes before the beginning of surgery. A tubular director that allows 1.0-1.5 cm of a 15-cm-long, 22-gauge needle to protrude beyond its tip will be used to guide the needle into the pudendal trunk at lesser sciatic foramen about 1 cm inferior-medial to attachment of the sacrospinous ligament to the ischial spine. The end of the director will be placed against the vaginal epithelium just beneath the tip of the ischial spine. The needle pushed beyond the tip of the director, and 5 ml of the anaesthetic solution will be injected. The needle advanced 1 cm posterior and lateral, and another 5 mL of the anaesthetic solution will be injected into this region. Aspiration will be attempted before every injection to guard against intravascular infusion.
Pain assessment protocols:
investigators will use a validated visual analogue pain scale at 1, 3, 5, 7, 18, 24 and 36 hours after surgery to assess postoperative pain intensity. This pain scale provides a validated and minimally intrusive measure of pain intensity, consisting of a 10-cm vertical line with the two endpoints labelled "no pain" and "worst possible pain." The patient is required to mark the 10-cm line at a point that corresponds to the present level of pain intensity. The distance in centimetres from the low end of the visual analogue scale and the patient's mark are used as a numerical index of pain intensity. To ensure that the questions will be asked in the same way each time, the nursing staff will be trained and instructed to phrase the questions in a standardized fashion, using the specific wording, as follows: "How bad is participant's pain? and mark participant's pain intensity on the pain scale from 0 to 10, where 0 indicates no pain and 10 indicate the worst possible pain. Analgesic requirements will consistently be recorded at 1, 3, 7, 18, and 24 hours after surgery.
Post-operative analgesia:
All patients will be given the following, unless allergic, Paracetamol 1 gm orally every 4 hours, and non-steroidal analgesia in the form of ibuprofen 400 mg orally 8 hourly, to diclofenac 50 mg rectally, 8 hourly, and Tramadol, up to 100 mg orally 8 hourly as required, and analgesia requirement will tabulate in the chart.
Statistical analysis:
Data collection Data will be collected on a customized case report form that includes all relevant demographic and intra-operative data as well as each outcome sought. Patients will be provided with a home diary to complete that will capture all outcomes sought that are not obtained in the hospital. Demographic data will be summarized and expressed using appropriate measures of central tendency and dispersion for continuous data, and frequency for categorical data. The primary outcome, time to the first sensation of pain at the surgical site, will be summarized as mean [SD] or median [IQR] after testing the data for normality with the Kolmogorov Smirnoff test. This will also determine whether groups will be compared with the t-test [for normally distributed data] or Kaplan Meier Survival Curves [for skewed data]. Secondary outcomes that are time-based will also be assessed in the above manner [time to first analgesic request, duration of motor block]. Continuous secondary outcomes [opioid consumption, VRS, room air SpO2] will be assessed with repeated measures ANOVA or the Mann Whitney U-test for non-parametric data. Categorical outcomes will be compared with the Chi-square or Fisher's exact test as necessary.
Ethics:
The approval from the King Fahad Medical City institutional review board [IRB] is taken.
Budget:
Total Budget will be based on estimation according to cost and protocol, and IRF will be obtained
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Device: Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.bupivacaine 0.25% for pudendal block |
| Intervention arm | Experimental | Device: Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.ropivacaine 0.2 % for the pudendal block |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing posterior vaginal repair.
- Give informed written consent.
- Recruited from the urogynecology department, women specialized hospital, King Fahad Medical City, Riyadh
Key exclusion criteria (6 listed)
- Posterior vaginal repair combined with Uterine suspension procedures [sacrospinous suspension or uterosacral suspension]
- Allergy to high risk to use of bupivacaine or ropivacaine
- coagulopathy
- pre-existing neurologic deficit
- Chronic pain syndromes
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 |
|---|---|---|
| Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.Patients will receive a pudendal nerve block injection on each side as previously described 5-10 minutes before the beginning of surgery. A tubular director that allows 1.0-1.5 cm of a 15-cm-long, 22-gauge needle to protrude beyond its tip will be used to guide the needle into the pudendal trunk at lesser sciatic foramen about 1 cm inferior-medial to attachment of the sacrospinous ligament to the ischial spine. The end of the director will be placed against the vaginal epithelium just beneath the tip of the ischial spine. The needle pushed beyond the tip of the director, and 5 ml of the anaesthetic solution will be injected. The needle advanced 1 cm posterior and lateral, and another 5 mL of the anaesthetic solution will be injected into this region. | Device | Control arm, Intervention arm |
Primary outcome
post operative pain assessment
Time frame: change in pain score from one hour up to 36 hours after surgery will be recorded.
visual analogue scale for will be used for post operative pain assessment from scale 1 to 10. A higher score indicate worse outcome.
postoperative analgesic consumption.
Time frame: from one hour up to 36 hours after surgery will be recorded.
grams or miligrams of intravenous or oral analegesics will be recorded and minimum and maximum amount needed will be recorded. A higher amount indicate worse outcome. An average will be calculated.
4 secondary outcomes
Post-operative recovery
Time frame: up to 6 weeks follow up appointment.
Length of hospital stay.
Time frame: The stay in hospital up to 36 hours to 2 days
Adverse reaction of analgesic
Time frame: from 1 hour up to 36 hours postoperatively
Patient satisfaction
Time frame: up to 6 weeks postoperative followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: Undecided. Need to discuss an ethical committee for feasibility
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.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet. in people with Post-operative Pain After Posterior Vaginal Repair, run by Munazzah Rafique.
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 6 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: status not confirmed, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Al-Badr, FACOG, FRCSC (2889999, aalbadr@kfmc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain assessment (time frame: change in pain score from one hour up to 36 hours after surgery will be recorded.). The study lists 2 primary outcomes in all. 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 7 May 2019.