Comparison of Post-operative Pain in Short Versus Long Stitch for Laparotomy Closure

NCT ID: NCT03828409

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-11-30

Brief Summary

Laparotomy is a surgical procedure where an incision is made through the abdominal wall in order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main type of abdominal access. However, there were complications associated with laparotomy such as incisional hernia, post-operative pain, surgical site infection and burst abdomen. The anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The skin and parietal peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum, giving rise to post-operative laparotomy pain. It is reported that approximately 60% of patients who underwent laparotomy do complain of post-operative pain.

Techniques of abdominal wall closure has been constantly in order to develop an ideal suture technique to minimise wound complications. One of the most significant changes in abdominal closure technique was the introduction of mass closure technique, known as 'long stitch' (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of 4:1, achieved by the use of continuous sutures at one centimetre from rectus edge with inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS) was introduced in 1980s where it was reported to result in lower rate of incisional hernia and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture five millimetres from rectus edge with inter-suture distance of five millimetre as well. It incorporates only the linea alba, which may reduce tension and post-operative pain.Studies has indicate that approximately 40% of post-operative patients reported inadequate pain relief despite therapeutic intervention. Inadequate pain control is associated with complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic event, cardiac morbidity, insomnia, ileus and poor wound healing The Visual Analog Scale (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A more objective way to evaluate the post-operative pain is to assess the usage of patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for post-operative patient is morphine. As SS relies on less tension and proper distribution of force along the fascial plane, it is possible that it might reduce post-operative pain as compared to LS technique. It can be assessed using total usage of analgesia (intravenous infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric rating scales (NRS) at that particular time. There is no study that evaluate post-operative pain difference between SS and LS technique.

The hypothesis of this study is that SS will reduce PCA morphine usage after midline laparotomy, which translate into reduction in post-operative pain. In order to detect the 30% reduction of PCA morphine, 86 patients are required.

Detailed Description

Laparotomy is a surgical procedure where an incision is made through the abdominal wall in order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main type of abdominal access However, there were complications associated with laparotomy such as incisional hernia, post-operative pain, surgical site infection and burst abdomen. The anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The rectus abdominis muscles is covered by rectus sheath, formed by aponeurosis of the internal oblique muscles except posterior layer from the arcuate line downwards. The sheath contains the ends of the lower six thoracic nerves (T7-T12) with first lumbar nerve The skin and parietal peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum, giving rise to post-operative laparotomy pain. It is reported that approximately 60% of patients who underwent laparotomy do complain of post-operative pain.

Techniques of abdominal wall closure has been constantly revised in order to develop an ideal suture technique to minimise wound complications. One of the most significant changes in abdominal closure technique was the introduction of mass closure technique, known as 'long stitch' (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of 4:1, achieved by the use of continuous sutures at one centimetre from rectus edge with inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS) was introduced in 1980s where it was reported to result in lower rate of incisional hernia and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture five millimetres from rectus edge with inter-suture distance of five millimetre as well. It incorporates only the linea alba, which may reduce tension and post-operative pain.

Effective post-operative pain management is an important aspect in surgical patient care. Studies has indicate that approximately 40% of post-operative patients reported inadequate pain relief despite therapeutic intervention. Inadequate pain control is associated with complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic event, cardiac morbidity, insomnia, ileus and poor wound healing. The Visual Analog Scale (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A more objective way to evaluate the post-operative pain is to assess the usage of patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for post-operative patient is morphine. As SS relies on less tension and proper distribution of force along the fascial plane, it is possible that it might reduce post-operative pain as compared to LS technique. It can be assessed using total usage of analgesia (intravenous infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric rating scales (NRS) at that particular time. There is no study that evaluate post-operative pain difference between SS and LS technique.

This is a prospective, multi-centered, double-blind randomized controlled trial to look into comparison of post-operative pain after elective laparotomy: short versus long stitch technique of closure in two tertiary hospitals. The study started in January 2017 and completed in November 2018. Patient who fulfilled the criteria of recruitment were included into this study.

In order to detect difference of 30% of PCA morphine usage, 86 patients are required. Both group of patients will received equal pre-operative analgesia, antibiotics and induction again. Patients will be randomized into LS and SS group. Once the aim of the surgery is achieved, the operating surgeon will open the sealed enveloped, which contain the group and technique of suture used. Postoperatively patient will be receiving oral paracetamol and taught on PCA morphine usage. PCA morphine usage and VAS score will be assessed by medical officer that are blinded to the treatment. Primary outcome is PCA morphine usage 24 hours post-surgery. Secondary outcome are presence of surgical site infection and length of hospital stay. Patients will subsequently be discharged by the surgeon in charge based on the discharge criteria. Patients will be follow-up in outpatient clinic on same interval. Presence of adverse events or complications will be documented.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Short stitch

short stitch used as one arm

Group Type: ACTIVE_COMPARATOR

Short stitch

Intervention Type: PROCEDURE

The rectus sheath are cleaned off the subcutaneous fats. Short stitch technique uses smaller needle and suture material. The suture is placed nearer to each other as compared to our conventional long stitch technique. It has inter-suture distance of 5mm and 5mm distance from rectus edge. The suture will be started at one end and sutured continuous until the other end. Hence, this technique is applied without tension.

Long stitch

Intervention Type: PROCEDURE

Long stitch uses a larger needle and suture material. The suture is placed 1cm from the linea alba and 1 cm from previous suture. This technique include mass closure sutures at the midline laparotomy

Long stitch

Long stitch as conventional mass-closure technique

Group Type: ACTIVE_COMPARATOR

Short stitch

Intervention Type: PROCEDURE

The rectus sheath are cleaned off the subcutaneous fats. Short stitch technique uses smaller needle and suture material. The suture is placed nearer to each other as compared to our conventional long stitch technique. It has inter-suture distance of 5mm and 5mm distance from rectus edge. The suture will be started at one end and sutured continuous until the other end. Hence, this technique is applied without tension.

Long stitch

Intervention Type: PROCEDURE

Long stitch uses a larger needle and suture material. The suture is placed 1cm from the linea alba and 1 cm from previous suture. This technique include mass closure sutures at the midline laparotomy

Interventions

Short stitch

The rectus sheath are cleaned off the subcutaneous fats. Short stitch technique uses smaller needle and suture material. The suture is placed nearer to each other as compared to our conventional long stitch technique. It has inter-suture distance of 5mm and 5mm distance from rectus edge. The suture will be started at one end and sutured continuous until the other end. Hence, this technique is applied without tension.

Intervention Type: PROCEDURE

Long stitch

Long stitch uses a larger needle and suture material. The suture is placed 1cm from the linea alba and 1 cm from previous suture. This technique include mass closure sutures at the midline laparotomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Elective primary midline laparotomy,
• ASA Class I to III
• hemodynamically stable
• able to provide consent for surgery

Exclusion Criteria

• Emergency laparotomy
• pregnancy
• history of previous midline laparotomy
• allergic to opiates
• unable to use PCA morphine (handicapped)
• patient will be planned for stoma creation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NMRR-16-1892-32723

Identifier Type: -

Identifier Source: org_study_id