PainPhase 4NCT02790099
Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine
A Phase 4 study testing Bupivacaine and Morphine in people with Pain, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2014to Jun 2016
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned for elective lower segment Caesarean section, using suprapubic transverse incision
- Willing and able to participate after the study has been explained
- Those understand either Cantonese, Putonghua or English
Who cannot join
- Patient with treatment for chronic pain
- History of narcotic abuse/ recreational drug use
- Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs
- Patient with pre-eclampsia
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Obstetrics and Gynaecology, Queen Mary Hospital
Hong Kong, Hong Kong
About this study
Official title: Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section
Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.
Read the detailed description
The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.
Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.
Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.
On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.
Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.
- Conditions
- Pain
- Being tested
- Bupivacaine, Morphine
- Keywords
- Pain, Postoperative pain control, Rectus sheath block, Intrathecal morphine, Caesarean section
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcain
Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.
MorphineDrug
0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block only | Experimental | Patient will be given surgical rectus sheath block postoperatively with 40ml of bupivacaine (2.5mg/mL) and 0.1ml of normal saline will be injected intrathecally at time of spinal anaesthesia. Receives: Drug: Bupivacaine |
| Intrathecal morphine group | Active comparator | 0.1mg preservative free morphine will be injected intrathecally at time of spinal anesthesia and 40ml of normal saline will be injected as rectus sheath block. Receives: Drug: Morphine |
| Both intervention | Active comparator | Patient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml). Receives: Drug: Bupivacaine; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Measured: at 12 hours postoperatively
Secondary outcomes (7)
Requirement of oral analgesics
Paracetamol 1gram four times a day on request basis will be prescribed. The number of time requiring paracetamol will be recorded. The need of additional analgesics will be recorded.
Measured: within 24hours postoperatively
Time of mobilization
time of starting mobilization, defined as able to get out of bed without assistance
Measured: 3days postoperatively
Side effect
side effects including itchiness, nausea/ vomiting, sedation
Measured: 3days postoperatively
Pain score
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10), will be accessed at the recovery room after the operation.
Measured: Immediate postoperative
Pain score
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Measured: 4hours postoperatively
Pain score
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Measured: 8hrs postoperatively
Pain score
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
Measured: 24hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lui Man Wa, Queen Mary Hospital, Hong Kong
- Investigators
- Ernest H. Y. Ng, Study chair, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790099
- Sponsor's protocol ID
- UW 14-345
- Status last verified
- Oct 2016
- First submitted
- 21 May 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: That's for patient privacy that individual participant data will not be available.
Publications
Uchiyama A, Nakano S, Ueyama H, Nishimura M, Tashiro C. Low dose intrathecal morphine and pain relief following caesarean section. Int J Obstet Anesth. 1994 Apr;3(2):87-91. doi: 10.1016/0959-289x(94)90175-9.
PubMed 15636923Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
PubMed 10598635Sawi W, Choy YC. A comparative study of post operative analgesia, side effects profile and patient satisfaction using intrathecal fentanyl with and without morphine 0.1 mg in caesarean section. Middle East J Anaesthesiol. 2013 Feb;22(1):21-6.
PubMed 23833846Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
PubMed 18428988Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner SC, Wanzel O, Kapral S. Ultrasonography-guided rectus sheath block in paediatric anaesthesia--a new approach to an old technique. Br J Anaesth. 2006 Aug;97(2):244-9. doi: 10.1093/bja/ael143. Epub 2006 Jun 23.
PubMed 16798774Niklasson B, Borjesson A, Carmnes UB, Segerdahl M, Ohman SG, Blanck A. Intraoperative injection of bupivacaine-adrenaline close to the fascia reduces morphine requirements after cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1433-9. doi: 10.1111/j.1600-0412.2012.01480.x. Epub 2012 Nov 1.
PubMed 22686512Crosbie EJ, Massiah NS, Achiampong JY, Dolling S, Slade RJ. The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):196-200. doi: 10.1016/j.ejogrb.2011.10.015. Epub 2011 Nov 21.
PubMed 22104479
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section
- ClinicalTrials.gov ID
- NCT02790099
- Acronym / sponsor ID
- UW 14-345
- Conditions
- Pain
- Keywords
- Pain, Postoperative pain control, Rectus sheath block, Intrathecal morphine, Caesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- 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.
Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.
Detailed description
The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.
Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.
Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.
On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.
Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block only | Experimental | Drug: BupivacainePatient will be given surgical rectus sheath block postoperatively with 40ml of bupivacaine (2.5mg/mL) and 0.1ml of normal saline will be injected intrathecally at time of spinal anaesthesia. |
| Intrathecal morphine group | Active comparator | Drug: Morphine0.1mg preservative free morphine will be injected intrathecally at time of spinal anesthesia and 40ml of normal saline will be injected as rectus sheath block. |
| Both intervention | Active comparator | Drug: Bupivacaine, Drug: MorphinePatient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned for elective lower segment Caesarean section, using suprapubic transverse incision
- Willing and able to participate after the study has been explained
- Those understand either Cantonese, Putonghua or English
Key exclusion criteria (4 listed)
- Patient with treatment for chronic pain
- History of narcotic abuse/ recreational drug use
- Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs
- Patient with pre-eclampsia
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 |
|---|---|---|
| BupivacaineAlso: MarcainSurgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation. | Drug | Both intervention, Rectus sheath block only |
| Morphine0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia. | Drug | Both intervention, Intrathecal morphine group |
Primary outcome
Pain score
Time frame: at 12 hours postoperatively
Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)
7 secondary outcomes
Requirement of oral analgesics
Time frame: within 24hours postoperatively
Time of mobilization
Time frame: 3days postoperatively
Side effect
Time frame: 3days postoperatively
Pain score
Time frame: Immediate postoperative
Pain score
Time frame: 4hours postoperatively
Pain score
Time frame: 8hrs postoperatively
Pain score
Time frame: 24hrs 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 4 Oct 2016.
- Background: PubMed 15636923Uchiyama A, Nakano S, Ueyama H, Nishimura M, Tashiro C. Low dose intrathecal morphine and pain relief following caesarean section. Int J Obstet Anesth. 1994 Apr;3(2):87-91. doi: 10.1016/0959-289x(94)90175-9.
- Background: PubMed 10598635Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
- Background: PubMed 23833846Sawi W, Choy YC. A comparative study of post operative analgesia, side effects profile and patient satisfaction using intrathecal fentanyl with and without morphine 0.1 mg in caesarean section. Middle East J Anaesthesiol. 2013 Feb;22(1):21-6.
- Background: PubMed 18428988Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
- Results publication: PubMed 16798774Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner SC, Wanzel O, Kapral S. Ultrasonography-guided rectus sheath block in paediatric anaesthesia--a new approach to an old technique. Br J Anaesth. 2006 Aug;97(2):244-9. doi: 10.1093/bja/ael143. Epub 2006 Jun 23.
- Results publication: PubMed 22686512Niklasson B, Borjesson A, Carmnes UB, Segerdahl M, Ohman SG, Blanck A. Intraoperative injection of bupivacaine-adrenaline close to the fascia reduces morphine requirements after cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1433-9. doi: 10.1111/j.1600-0412.2012.01480.x. Epub 2012 Nov 1.
- Results publication: PubMed 22104479Crosbie EJ, Massiah NS, Achiampong JY, Dolling S, Slade RJ. The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):196-200. doi: 10.1016/j.ejogrb.2011.10.015. Epub 2011 Nov 21.
- Individual participant dataSharing planned: No. That's for patient privacy that individual participant data will not be available.
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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.
Ernest H. Y. Ng study chair
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Morphine in people with Pain, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
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 4 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score (time frame: at 12 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790099, which also lists 7 linked publications.
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 4 Oct 2016.